Businesses
Here's a look at documents from U.S. and international businesses
Featured Stories
Sage Launches Disinformation: An Interdisciplinary Journal
THOUSAND OAKS, California, Sept. 26 (TNSrep) -- SAGE Publishing issued the following news release:
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Sage launches Disinformation: An Interdisciplinary Journal
Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open access journal examining how disinformation is produced, circulated, and understood across societies and cultures.
September 24, 2026
New open access journal advances research on disinformation and its societal impacts
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Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open access ... Show Full Article THOUSAND OAKS, California, Sept. 26 (TNSrep) -- SAGE Publishing issued the following news release: * * * Sage launches Disinformation: An Interdisciplinary Journal Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open access journal examining how disinformation is produced, circulated, and understood across societies and cultures. September 24, 2026 New open access journal advances research on disinformation and its societal impacts - Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open accessjournal examining how disinformation is produced, circulated, and understood across societies and cultures.
Launching in January 2027 and now accepting submissions, the journal welcomes contributions exploring disinformation in contexts including politics and elections, war and conflict, science, health, climate change, and the environment. Alongside theoretical, empirical, and methodological research, Disinformation will feature an Interventions and Commentary section, creating a forum for timely dialogue between researchers and practitioners working to understand and address disinformation.
An editorial collective will lead the journal, with a different member serving as managing editor each year. Together, the collective brings global expertise spanning digital media, communication, climate communication, political communication, rhetoric, and disinformation studies.
"We're excited to launch Disinformation: An Interdisciplinary Journal at a moment when disinformation is more rife than ever, and when the term itself is hotly contested," said the Editors. "The journal will be a forum both for studying how disinformation spreads, and for critically interrogating what gets labelled as disinformation, and why."
"Disinformation is a pressing challenge for societies around the world, and understanding it requires perspectives from across disciplines and cultures," said Rachel Hunter, Vice President, Journals Editorial at Sage. "The launch of Disinformation: An Interdisciplinary Journal is timely as the need for rigorous research and debate in this area is more important than ever. Through international and interdisciplinary collaboration, this journal will help deepen understanding of disinformation, its impact and how societies respond to it."
The journal encourages international perspectives and contributions by researchers from the Global South. Its editorial collective comprises Niki Cheong, King's College London, UK; Gabi Mocatta, University of Tasmania, Australia; Raquel Recuero, Universidade Federal de Pelotas, Brazil; Felipe Bonow Soares, University of the Arts London, UK; and Robert Topinka, Birkbeck, University of London, UK.
Disinformation will be published through Sage Community Open Access (https://www.sagepub.com/journals/information-for-authors/publishing-options/community-open-access), an initiative that enables selected journals to publish with no fees for authors and no barriers for readers - one of several flexible publishing options Sage offers to support sustainable and accessible research.
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Original text here: https://www.sagepub.com/explore-our-content/press-office/press-releases/2026/09/24/sage-launches-disinformation--an-interdisciplinary-journal
[Category: BizMedia]
* * *
Sage launches Disinformation: An Interdisciplinary Journal
Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open access journal examining how disinformation is produced, circulated, and understood across societies and cultures.
September 24, 2026
New open access journal advances research on disinformation and its societal impacts
-
Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open access ... Show Full Article THOUSAND OAKS, California, Sept. 26 (TNSrep) -- SAGE Publishing issued the following news release: * * * Sage launches Disinformation: An Interdisciplinary Journal Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open access journal examining how disinformation is produced, circulated, and understood across societies and cultures. September 24, 2026 New open access journal advances research on disinformation and its societal impacts - Sage announces the launch of Disinformation: An Interdisciplinary Journal, a new peer-reviewed, open accessjournal examining how disinformation is produced, circulated, and understood across societies and cultures.
Launching in January 2027 and now accepting submissions, the journal welcomes contributions exploring disinformation in contexts including politics and elections, war and conflict, science, health, climate change, and the environment. Alongside theoretical, empirical, and methodological research, Disinformation will feature an Interventions and Commentary section, creating a forum for timely dialogue between researchers and practitioners working to understand and address disinformation.
An editorial collective will lead the journal, with a different member serving as managing editor each year. Together, the collective brings global expertise spanning digital media, communication, climate communication, political communication, rhetoric, and disinformation studies.
"We're excited to launch Disinformation: An Interdisciplinary Journal at a moment when disinformation is more rife than ever, and when the term itself is hotly contested," said the Editors. "The journal will be a forum both for studying how disinformation spreads, and for critically interrogating what gets labelled as disinformation, and why."
"Disinformation is a pressing challenge for societies around the world, and understanding it requires perspectives from across disciplines and cultures," said Rachel Hunter, Vice President, Journals Editorial at Sage. "The launch of Disinformation: An Interdisciplinary Journal is timely as the need for rigorous research and debate in this area is more important than ever. Through international and interdisciplinary collaboration, this journal will help deepen understanding of disinformation, its impact and how societies respond to it."
The journal encourages international perspectives and contributions by researchers from the Global South. Its editorial collective comprises Niki Cheong, King's College London, UK; Gabi Mocatta, University of Tasmania, Australia; Raquel Recuero, Universidade Federal de Pelotas, Brazil; Felipe Bonow Soares, University of the Arts London, UK; and Robert Topinka, Birkbeck, University of London, UK.
Disinformation will be published through Sage Community Open Access (https://www.sagepub.com/journals/information-for-authors/publishing-options/community-open-access), an initiative that enables selected journals to publish with no fees for authors and no barriers for readers - one of several flexible publishing options Sage offers to support sustainable and accessible research.
* * *
Original text here: https://www.sagepub.com/explore-our-content/press-office/press-releases/2026/09/24/sage-launches-disinformation--an-interdisciplinary-journal
[Category: BizMedia]
Powering the Next Generation: DTE Lays Out Plan to Deliver a Cleaner, Reliable Energy Future for Michigan Customers
DETROIT, Michigan, Sept. 26 -- DTE Energy issued the following news release:
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Powering the next generation: DTE lays out plan to deliver a cleaner, reliable energy future for Michigan customers
New 20-year plan is $3.5 billion less expensive than previous filing - continues to retire coal in 2032, adds renewable energy and reliable power generation to support Michigan's growing economy and meet the state's clean energy requirements
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DETROIT, Sept. 24, 2026 - DTE Electric today filed its long-range plan with the Michigan Public Service Commission (MPSC), outlining how the company plans ... Show Full Article DETROIT, Michigan, Sept. 26 -- DTE Energy issued the following news release: * * * Powering the next generation: DTE lays out plan to deliver a cleaner, reliable energy future for Michigan customers New 20-year plan is $3.5 billion less expensive than previous filing - continues to retire coal in 2032, adds renewable energy and reliable power generation to support Michigan's growing economy and meet the state's clean energy requirements - DETROIT, Sept. 24, 2026 - DTE Electric today filed its long-range plan with the Michigan Public Service Commission (MPSC), outlining how the company plansto reliably generate power for its customers over the next 20 years while ending its use of coal in 2032 and complying with Michigan's clean energy and renewable energy standards. Backed by extensive customer input, the Integrated Resource Plan (IRP) is designed to keep power reliable and bills as low as possible by using an "all of the above" mix of energy sources, including renewable energy, energy storage, nuclear power and natural gas.
"We're building a stronger tomorrow for Michigan's children and grandchildren," said Joi Harris, president and CEO of DTE Energy. "We listened closely to our customers throughout this process, and this plan reflects what they told us matters most to them: reliable power, affordable bills and a practical path to a cleaner energy future. It balances those priorities while ensuring Michigan has the energy it needs to continue growing for decades to come."
With reliability, affordability and compliance behind every decision - the plan is expected to be $3.5 billion less expensive than the company's previous IRP (2022) after accounting for multiple factors including evolved pricing and other market dynamics, as well as changing energy laws.
A balanced plan to replace coal
As DTE prepares to end coal use in 2032, the company plans to replace that power with energy sources that work together to serve customers day and night, in every season. The plan includes:
* Reaffirming the retirement of all coal in 2032. The first phase of the Monroe Power Plant closure will take place in 2028, with the final phase occurring in 2032, retiring approximately 3 gigawatts of generation capacity. In 2005, coal accounted for 62% of DTE's generation capacity. By 2033, DTE will not operate a single coal plant.
* Reducing carbon dioxide emissions. The plan reduces carbon dioxide emissions by 84%, driven by the retirement of Monroe Power Plant, the continued addition of renewables and storage and the addition of efficient, state-of-the-art natural gas plants. Once carbon capture and storage is implemented, more than 90% carbon reduction will be achieved.
* Adding more renewable energy and storage. The plan adds 15 gigawatts of renewables, along with 4.5 gigawatts of energy storage to help maintain system reliability and meet Michigan's clean energy and renewable energy standard requirements.
* Increasing nuclear power. The plan upgrades the existing Fermi 2 nuclear plant so it can produce 177 more megawatts of reliable, carbon-free electricity beginning in 2036.
* Building dependable natural gas power that is available when customers need it. A proposal for two new state-of-the-art natural gas plants totaling 2.1 gigawatts that would provide dependable, around-the-clock power when customers need electricity most, regardless of weather and in periods of high demand.
* Helping customers use less energy. The growth of demand response programs like CoolCurrents and Smart Savers helps customers lower energy consumption during peak times. The proposed plan includes a virtual power plant that would leverage participating batteries located in homes and businesses to help reduce demand when the electric grid needs support.
Shaped by customers and experts
"As we retire coal in 2032, our job is to replace that power with resources that work together around the clock -- renewables, storage, nuclear and natural gas," said Matt Paul, president of DTE Electric. "We designed this plan to be achievable and affordable -- grounded in real analysis and feedback from customers and built to deliver cleaner energy while meeting Michigan's growing needs for the next 20 years and beyond."
DTE built the plan with input from customers, communities, businesses and energy experts. The company surveyed more than 1,500 residential and business customers, held 15 engagement sessions reaching more than 10 environmental justice communities and hosted five technical workshops with participation from more than 50 organizations. The feedback received from these engagements helped shape a plan focused on affordability, reliability and cleaner energy.
Protecting customers as Michigan grows
DTE also evaluated more than 100 different energy scenarios to compare how various resource options would perform across a range of future conditions. The resulting analysis helped the company identify a proposed plan designed to meet reliability and environmental requirements while keeping bills as low as possible.
The plan accounts for DTE Electric customers' growing needs over the next 20 years, including economic development, increased electrification and distributed generation adoption, and recommends a path forward that ensures continued reliability for all customers, big and small.
What happens next
The Michigan Public Service Commission will review DTE's IRP through a regulatory process that includes analysis and stakeholder input before a final decision, which can take up to 360 days.
* * *
About DTE Energy
DTE Energy (NYSE:DTE) is a Detroit-based diversified energy company involved in the development and management of energy-related businesses and services nationwide. Its operating units include an electric company serving 2.3 million customers in Southeast Michigan and a natural gas company serving 1.4 million customers across Michigan. The DTE portfolio also includes energy businesses focused on custom energy solutions, renewable energy generation, and energy marketing and trading. DTE has continued to accelerate its carbon reduction goals to meet aggressive targets and is committed to serving with its energy through volunteerism, education and employment initiatives, philanthropy, emission reductions and economic progress. Information about DTE is available at dteenergy.com, empoweringmichigan.com, x.com/DTE_Energy and facebook.com/dteenergy.
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Original text here: https://www.dteenergy.com/us/en/newsroom/2026/Powering-the-next-generation--DTE-lays-out-plan-to-deliver-a-cleaner,-reliable-energy-future-for-Michigan-customers.html
[Category: BizEnergy]
* * *
Powering the next generation: DTE lays out plan to deliver a cleaner, reliable energy future for Michigan customers
New 20-year plan is $3.5 billion less expensive than previous filing - continues to retire coal in 2032, adds renewable energy and reliable power generation to support Michigan's growing economy and meet the state's clean energy requirements
-
DETROIT, Sept. 24, 2026 - DTE Electric today filed its long-range plan with the Michigan Public Service Commission (MPSC), outlining how the company plans ... Show Full Article DETROIT, Michigan, Sept. 26 -- DTE Energy issued the following news release: * * * Powering the next generation: DTE lays out plan to deliver a cleaner, reliable energy future for Michigan customers New 20-year plan is $3.5 billion less expensive than previous filing - continues to retire coal in 2032, adds renewable energy and reliable power generation to support Michigan's growing economy and meet the state's clean energy requirements - DETROIT, Sept. 24, 2026 - DTE Electric today filed its long-range plan with the Michigan Public Service Commission (MPSC), outlining how the company plansto reliably generate power for its customers over the next 20 years while ending its use of coal in 2032 and complying with Michigan's clean energy and renewable energy standards. Backed by extensive customer input, the Integrated Resource Plan (IRP) is designed to keep power reliable and bills as low as possible by using an "all of the above" mix of energy sources, including renewable energy, energy storage, nuclear power and natural gas.
"We're building a stronger tomorrow for Michigan's children and grandchildren," said Joi Harris, president and CEO of DTE Energy. "We listened closely to our customers throughout this process, and this plan reflects what they told us matters most to them: reliable power, affordable bills and a practical path to a cleaner energy future. It balances those priorities while ensuring Michigan has the energy it needs to continue growing for decades to come."
With reliability, affordability and compliance behind every decision - the plan is expected to be $3.5 billion less expensive than the company's previous IRP (2022) after accounting for multiple factors including evolved pricing and other market dynamics, as well as changing energy laws.
A balanced plan to replace coal
As DTE prepares to end coal use in 2032, the company plans to replace that power with energy sources that work together to serve customers day and night, in every season. The plan includes:
* Reaffirming the retirement of all coal in 2032. The first phase of the Monroe Power Plant closure will take place in 2028, with the final phase occurring in 2032, retiring approximately 3 gigawatts of generation capacity. In 2005, coal accounted for 62% of DTE's generation capacity. By 2033, DTE will not operate a single coal plant.
* Reducing carbon dioxide emissions. The plan reduces carbon dioxide emissions by 84%, driven by the retirement of Monroe Power Plant, the continued addition of renewables and storage and the addition of efficient, state-of-the-art natural gas plants. Once carbon capture and storage is implemented, more than 90% carbon reduction will be achieved.
* Adding more renewable energy and storage. The plan adds 15 gigawatts of renewables, along with 4.5 gigawatts of energy storage to help maintain system reliability and meet Michigan's clean energy and renewable energy standard requirements.
* Increasing nuclear power. The plan upgrades the existing Fermi 2 nuclear plant so it can produce 177 more megawatts of reliable, carbon-free electricity beginning in 2036.
* Building dependable natural gas power that is available when customers need it. A proposal for two new state-of-the-art natural gas plants totaling 2.1 gigawatts that would provide dependable, around-the-clock power when customers need electricity most, regardless of weather and in periods of high demand.
* Helping customers use less energy. The growth of demand response programs like CoolCurrents and Smart Savers helps customers lower energy consumption during peak times. The proposed plan includes a virtual power plant that would leverage participating batteries located in homes and businesses to help reduce demand when the electric grid needs support.
Shaped by customers and experts
"As we retire coal in 2032, our job is to replace that power with resources that work together around the clock -- renewables, storage, nuclear and natural gas," said Matt Paul, president of DTE Electric. "We designed this plan to be achievable and affordable -- grounded in real analysis and feedback from customers and built to deliver cleaner energy while meeting Michigan's growing needs for the next 20 years and beyond."
DTE built the plan with input from customers, communities, businesses and energy experts. The company surveyed more than 1,500 residential and business customers, held 15 engagement sessions reaching more than 10 environmental justice communities and hosted five technical workshops with participation from more than 50 organizations. The feedback received from these engagements helped shape a plan focused on affordability, reliability and cleaner energy.
Protecting customers as Michigan grows
DTE also evaluated more than 100 different energy scenarios to compare how various resource options would perform across a range of future conditions. The resulting analysis helped the company identify a proposed plan designed to meet reliability and environmental requirements while keeping bills as low as possible.
The plan accounts for DTE Electric customers' growing needs over the next 20 years, including economic development, increased electrification and distributed generation adoption, and recommends a path forward that ensures continued reliability for all customers, big and small.
What happens next
The Michigan Public Service Commission will review DTE's IRP through a regulatory process that includes analysis and stakeholder input before a final decision, which can take up to 360 days.
* * *
About DTE Energy
DTE Energy (NYSE:DTE) is a Detroit-based diversified energy company involved in the development and management of energy-related businesses and services nationwide. Its operating units include an electric company serving 2.3 million customers in Southeast Michigan and a natural gas company serving 1.4 million customers across Michigan. The DTE portfolio also includes energy businesses focused on custom energy solutions, renewable energy generation, and energy marketing and trading. DTE has continued to accelerate its carbon reduction goals to meet aggressive targets and is committed to serving with its energy through volunteerism, education and employment initiatives, philanthropy, emission reductions and economic progress. Information about DTE is available at dteenergy.com, empoweringmichigan.com, x.com/DTE_Energy and facebook.com/dteenergy.
* * *
Original text here: https://www.dteenergy.com/us/en/newsroom/2026/Powering-the-next-generation--DTE-lays-out-plan-to-deliver-a-cleaner,-reliable-energy-future-for-Michigan-customers.html
[Category: BizEnergy]
Newmark Arranges $125M Sale of Deer Park Town Center, Premier Lifestyle Destination in Chicago's Northwest Suburbs
NEW YORK, Sept. 26 -- Newmark Group, a commercial real estate company that says they offer comprehensive suite of services and products, posted the following news release:
* * *
Newmark Arranges $125M Sale of Deer Park Town Center, Premier Lifestyle Destination in Chicago's Northwest Suburbs
September 25, 2026
Newmark announces the Company has arranged the $125 million sale of Deer Park Town Center, a 352,257-square-foot open-air lifestyle center located in Deer Park, Illinois, within Chicago's affluent northwest suburban corridor.
Newmark President and Head of Retail Capital Markets Conor ... Show Full Article NEW YORK, Sept. 26 -- Newmark Group, a commercial real estate company that says they offer comprehensive suite of services and products, posted the following news release: * * * Newmark Arranges $125M Sale of Deer Park Town Center, Premier Lifestyle Destination in Chicago's Northwest Suburbs September 25, 2026 Newmark announces the Company has arranged the $125 million sale of Deer Park Town Center, a 352,257-square-foot open-air lifestyle center located in Deer Park, Illinois, within Chicago's affluent northwest suburban corridor. Newmark President and Head of Retail Capital Markets ConorLalor and Senior Managing Directors Kyle Minter and Keely Polczynski represented seller PGIM in the transaction, with support from Director James Sharpe V and Associate Director Brian Schneiderman. The buyer was a joint venture of Brand Street Properties and AEW Capital Management, L.P.
Located at 20530 N. Rand Road, Deer Park Town Center is one of the Chicago region's preeminent lifestyle retail destinations, serving a highly affluent customer base with a curated mix of national retailers, restaurants and experiential concepts. Built in 2000, the center was approximately 84.6% occupied at the time of sale and features more than 45 retailers and dining destinations.
"Deer Park Town Center represented a rare opportunity to acquire a dominant open-air lifestyle asset in one of the Midwest's most desirable retail trade areas," said Lalor. "The property's exceptional demographics, premier merchandising profile and embedded value-creation opportunities generated significant interest from investors seeking high-quality retail real estate."
The center is anchored by a roster of nationally recognized tenants, including Anthropologie, Crate & Barrel, Pottery Barn, Sephora, lululemon, Apple and Warby Parker, among others. The property's strong merchandising mix and experiential environment attract approximately 3 million visitors annually and have established Deer Park Town Center as a leading fashion, dining and lifestyle destination in the Chicago metropolitan area.
Over the past several years, ownership completed approximately 74,000 square feet of leasing activity, securing commitments from a range of leading retailers including Sweetgreen, Tommy Bahama, Pandora, The Shade Store, Bluemercury, Joybird, American Eagle and Warby Parker. The continued leasing momentum reinforced the property's positioning as a preferred location for best-in-class retailers expanding throughout the Chicago market.
The asset benefits from strong demographics, including average household incomes of approximately $170,000 and a population exceeding 180,000 residents within a five-mile radius. Situated at the intersection of Rand Road and Long Grove Road, the property enjoys strong visibility and accessibility from traffic counts exceeding 50,000 vehicles per day.
* * *
About Newmark
Newmark Group, Inc. (Nasdaq: NMRK), together with its subsidiaries ("Newmark"), is a world leading commercial real estate advisor and service provider to large institutional investors and other owners, global corporations and other occupiers, and lenders. Built with purpose and driven by excellence, Newmark's comprehensive platform is uniquely tailored to provide superior outcomes to clients. For the twelve months ended June 30, 2026, Newmark generated revenues of more than $3.6 billion. As of June 30, 2026, Newmark and its business partners together operated from over 195 offices with more than 10,000 professionals across four continents. Learn more at nmrk.com or follow @newmark.
* * *
Discussion of Forward-Looking Statements about Newmark
Statements in this document regarding Newmark that are not historical facts are "forward-looking statements" that involve risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements. These include statements about the Company's business, results, financial position, liquidity, and outlook, which may constitute forward-looking statements and are subject to the risk that the actual impact may differ, possibly materially, from what is currently expected. Except as required by law, Newmark undertakes no obligation to update any forward-looking statements. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see Newmark's Securities and Exchange Commission filings, including, but not limited to, the risk factors and Special Note on Forward-Looking Information set forth in these filings and any updates to such risk factors and Special Note on Forward-Looking Information contained in subsequent reports on Form 10-K, Form 10-Q or Form 8-K.
* * *
Original text here: https://www.nmrk.com/insights/press-releases/newmark-arranges-125m-sale-of-deer-park-town-center-premier-lifestyle-destination-in-chicagos-northwest-suburbs
[Category: BizReal Estate]
* * *
Newmark Arranges $125M Sale of Deer Park Town Center, Premier Lifestyle Destination in Chicago's Northwest Suburbs
September 25, 2026
Newmark announces the Company has arranged the $125 million sale of Deer Park Town Center, a 352,257-square-foot open-air lifestyle center located in Deer Park, Illinois, within Chicago's affluent northwest suburban corridor.
Newmark President and Head of Retail Capital Markets Conor ... Show Full Article NEW YORK, Sept. 26 -- Newmark Group, a commercial real estate company that says they offer comprehensive suite of services and products, posted the following news release: * * * Newmark Arranges $125M Sale of Deer Park Town Center, Premier Lifestyle Destination in Chicago's Northwest Suburbs September 25, 2026 Newmark announces the Company has arranged the $125 million sale of Deer Park Town Center, a 352,257-square-foot open-air lifestyle center located in Deer Park, Illinois, within Chicago's affluent northwest suburban corridor. Newmark President and Head of Retail Capital Markets ConorLalor and Senior Managing Directors Kyle Minter and Keely Polczynski represented seller PGIM in the transaction, with support from Director James Sharpe V and Associate Director Brian Schneiderman. The buyer was a joint venture of Brand Street Properties and AEW Capital Management, L.P.
Located at 20530 N. Rand Road, Deer Park Town Center is one of the Chicago region's preeminent lifestyle retail destinations, serving a highly affluent customer base with a curated mix of national retailers, restaurants and experiential concepts. Built in 2000, the center was approximately 84.6% occupied at the time of sale and features more than 45 retailers and dining destinations.
"Deer Park Town Center represented a rare opportunity to acquire a dominant open-air lifestyle asset in one of the Midwest's most desirable retail trade areas," said Lalor. "The property's exceptional demographics, premier merchandising profile and embedded value-creation opportunities generated significant interest from investors seeking high-quality retail real estate."
The center is anchored by a roster of nationally recognized tenants, including Anthropologie, Crate & Barrel, Pottery Barn, Sephora, lululemon, Apple and Warby Parker, among others. The property's strong merchandising mix and experiential environment attract approximately 3 million visitors annually and have established Deer Park Town Center as a leading fashion, dining and lifestyle destination in the Chicago metropolitan area.
Over the past several years, ownership completed approximately 74,000 square feet of leasing activity, securing commitments from a range of leading retailers including Sweetgreen, Tommy Bahama, Pandora, The Shade Store, Bluemercury, Joybird, American Eagle and Warby Parker. The continued leasing momentum reinforced the property's positioning as a preferred location for best-in-class retailers expanding throughout the Chicago market.
The asset benefits from strong demographics, including average household incomes of approximately $170,000 and a population exceeding 180,000 residents within a five-mile radius. Situated at the intersection of Rand Road and Long Grove Road, the property enjoys strong visibility and accessibility from traffic counts exceeding 50,000 vehicles per day.
* * *
About Newmark
Newmark Group, Inc. (Nasdaq: NMRK), together with its subsidiaries ("Newmark"), is a world leading commercial real estate advisor and service provider to large institutional investors and other owners, global corporations and other occupiers, and lenders. Built with purpose and driven by excellence, Newmark's comprehensive platform is uniquely tailored to provide superior outcomes to clients. For the twelve months ended June 30, 2026, Newmark generated revenues of more than $3.6 billion. As of June 30, 2026, Newmark and its business partners together operated from over 195 offices with more than 10,000 professionals across four continents. Learn more at nmrk.com or follow @newmark.
* * *
Discussion of Forward-Looking Statements about Newmark
Statements in this document regarding Newmark that are not historical facts are "forward-looking statements" that involve risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements. These include statements about the Company's business, results, financial position, liquidity, and outlook, which may constitute forward-looking statements and are subject to the risk that the actual impact may differ, possibly materially, from what is currently expected. Except as required by law, Newmark undertakes no obligation to update any forward-looking statements. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see Newmark's Securities and Exchange Commission filings, including, but not limited to, the risk factors and Special Note on Forward-Looking Information set forth in these filings and any updates to such risk factors and Special Note on Forward-Looking Information contained in subsequent reports on Form 10-K, Form 10-Q or Form 8-K.
* * *
Original text here: https://www.nmrk.com/insights/press-releases/newmark-arranges-125m-sale-of-deer-park-town-center-premier-lifestyle-destination-in-chicagos-northwest-suburbs
[Category: BizReal Estate]
Hughes Hubbard: Patrice Jean Named President of Columbia Law School Alumni Association
NEW YORK, Sept. 26 -- Hughes Hubbard and Reed, a law firm, issued the following news:
* * *
September 25, 2026
Patrice Jean Named President of Columbia Law School Alumni Association
Hughes Hubbard partner and Columbia Law alum will lead the school's global alumni community.
Highlights
* Patrice Jean has been named president of the Columbia Law School Alumni Association.
* Jean graduated from Columbia Law School in 2002.
* She plans to help strengthen engagement among Columbia Law graduates worldwide.
-
Patrice Jean has been named president of the Columbia Law School Alumni Association.
A ... Show Full Article NEW YORK, Sept. 26 -- Hughes Hubbard and Reed, a law firm, issued the following news: * * * September 25, 2026 Patrice Jean Named President of Columbia Law School Alumni Association Hughes Hubbard partner and Columbia Law alum will lead the school's global alumni community. Highlights * Patrice Jean has been named president of the Columbia Law School Alumni Association. * Jean graduated from Columbia Law School in 2002. * She plans to help strengthen engagement among Columbia Law graduates worldwide. - Patrice Jean has been named president of the Columbia Law School Alumni Association. A2002 graduate of Columbia Law School, Jean will help lead the association's efforts to strengthen connections among alumni and support the school's global community of more than 30,000 graduates.
In an address to her fellow Alumni Association members marking the start of the academic year, Jean reflected on her connection to the school and its students, as well as on the accomplishments of Columbia Law graduates and the bonds between them that continue long after graduation.
"Over the years, it has been an immense privilege to watch so many Columbia Law graduates... charting distinguished, groundbreaking careers that are reshaping the way law is understood and practiced," Jean said. "And all while we've maintained that collective bond."
Jean is Chair of Hughes Hubbard's Life Sciences Group. Prior to law school, she earned her Ph.D. in molecular biology from Princeton University.
* * *
Featured Lawyers
Patrice Jean
Partner
Locations
New York
patrice.jean@hugheshubbard.com
212/837-6264
* * *
Original text here: https://www.hugheshubbard.com/news-insights/news/patrice-jean-named-president-of-columbia-law-school-alumni-association
[Category: BizLaw/Legal]
* * *
September 25, 2026
Patrice Jean Named President of Columbia Law School Alumni Association
Hughes Hubbard partner and Columbia Law alum will lead the school's global alumni community.
Highlights
* Patrice Jean has been named president of the Columbia Law School Alumni Association.
* Jean graduated from Columbia Law School in 2002.
* She plans to help strengthen engagement among Columbia Law graduates worldwide.
-
Patrice Jean has been named president of the Columbia Law School Alumni Association.
A ... Show Full Article NEW YORK, Sept. 26 -- Hughes Hubbard and Reed, a law firm, issued the following news: * * * September 25, 2026 Patrice Jean Named President of Columbia Law School Alumni Association Hughes Hubbard partner and Columbia Law alum will lead the school's global alumni community. Highlights * Patrice Jean has been named president of the Columbia Law School Alumni Association. * Jean graduated from Columbia Law School in 2002. * She plans to help strengthen engagement among Columbia Law graduates worldwide. - Patrice Jean has been named president of the Columbia Law School Alumni Association. A2002 graduate of Columbia Law School, Jean will help lead the association's efforts to strengthen connections among alumni and support the school's global community of more than 30,000 graduates.
In an address to her fellow Alumni Association members marking the start of the academic year, Jean reflected on her connection to the school and its students, as well as on the accomplishments of Columbia Law graduates and the bonds between them that continue long after graduation.
"Over the years, it has been an immense privilege to watch so many Columbia Law graduates... charting distinguished, groundbreaking careers that are reshaping the way law is understood and practiced," Jean said. "And all while we've maintained that collective bond."
Jean is Chair of Hughes Hubbard's Life Sciences Group. Prior to law school, she earned her Ph.D. in molecular biology from Princeton University.
* * *
Featured Lawyers
Patrice Jean
Partner
Locations
New York
patrice.jean@hugheshubbard.com
212/837-6264
* * *
Original text here: https://www.hugheshubbard.com/news-insights/news/patrice-jean-named-president-of-columbia-law-school-alumni-association
[Category: BizLaw/Legal]
Fisher Phillips Issues Insight: EU Cyber Resilience Act Reporting Is Now Live - 7-Step Plan for Manufacturers Facing 24-Hour Deadlines
ATLANTA, Georgia, Sept. 26 -- Fisher Phillips, a law firm, issued the following Insight:
* * *
EU Cyber Resilience Act Reporting Is Now Live: A 7-Step Plan for Manufacturers Facing 24-Hour Deadlines
Sep 25, 2026
Manufacturers need to be aware of the European Union's cybersecurity law for products with digital elements. If your company sells a connected product, a software application, or a hardware component in the European Union, you are already on a 24-hour reporting clock. The EU Cyber Resilience Act's (CRA's) reporting requirements may apply even to products your company sold years ago, ... Show Full Article ATLANTA, Georgia, Sept. 26 -- Fisher Phillips, a law firm, issued the following Insight: * * * EU Cyber Resilience Act Reporting Is Now Live: A 7-Step Plan for Manufacturers Facing 24-Hour Deadlines Sep 25, 2026 Manufacturers need to be aware of the European Union's cybersecurity law for products with digital elements. If your company sells a connected product, a software application, or a hardware component in the European Union, you are already on a 24-hour reporting clock. The EU Cyber Resilience Act's (CRA's) reporting requirements may apply even to products your company sold years ago,and violations can trigger the law's highest penalties. Here's what manufacturers need to know about the reporting requirements that took effect September 11, which products are covered, and seven steps you should consider taking now to comply.
What the CRA Covers
The CRA establishes reporting obligations for actively exploited vulnerabilities and severe incidents. These requirements took effect on September 11, 2026, while the CRA's broader product-compliance regime does not apply until December 11, 2027. This cybersecurity law covers products with digital elements, which means software or hardware products and their remote data processing solutions, including software or hardware components placed on the market separately. The law's reach is broad, covering industrial controllers, connected consumer devices, operating systems, mobile applications, network equipment, and firmware.
Several categories, however, are not included because other EU regimes already govern their cybersecurity. Medical devices and in vitro diagnostics, type-approved motor vehicles, certified civil aviation equipment, and marine equipment are excluded. So are products developed or modified exclusively for national security or defense purposes, products designed to process classified information, and spare parts manufactured to the same specifications as the parts they replace.
Standalone software-as-a-service is generally outside the CRA. SaaS is captured only where it functions as a remote data processing solution, meaning remote processing that the manufacturer designs and develops and that the product could not perform its functions without. If your cloud service is the product rather than a component of a product, the CRA likely won't come into play, but NIS2 and DORA might.
Who Bears the Obligation
Manufacturers carry the reporting duty. A manufacturer is any natural or legal person that develops or manufactures products with digital elements, or has them designed, developed, or manufactured, and markets them under its own name or trademark, whether for payment, for monetization, or free of charge.
The product does not need to be created in the EU. Rather, the obligation is triggered when the product is placed on the EU market. A US company that sells into the EU through a distributor is a manufacturer under the CRA and must report. Manufacturers established outside the EU must also designate an authorized representative in the EU.
Importers and distributors do not file the reports themselves, but they do have some obligations. Both must inform the manufacturer without undue delay when becoming aware of a vulnerability in the product. Both must immediately inform the market surveillance authorities of the Member States where they made the product available if the product presents a significant cybersecurity risk.
An importer or distributor that markets a product under its own name or trademark, or that substantially modifies a product already on the market, becomes the manufacturer for CRA purposes and inherits the full reporting obligation. Be sure to carefully review private-label and white-label arrangements on this point.
Open-source software stewards are subject to a lighter, separate regime. The European Commission's stated position is that steward reporting obligations begin on December 11, 2027, not September 2026.
What Must Be Reported
The following two categories start the reporting clock:
* An actively exploited vulnerability, when there is reliable evidence that a malicious actor has exploited it in a system without the permission of the system owner. Good-faith security testing and coordinated disclosure without malicious intent do not trigger the duty.
* A severe incident that has an impact on the security of the product, meaning an incident that negatively affects or is capable of negatively affecting the product's ability to protect the availability, authenticity, integrity, or confidentiality of data or functions. It also covers an incident that has led or is capable of leading to the introduction or execution of malicious code in the product or in a user's network and information systems.
Importantly, a severe incident doesn't have to directly affect a customer. It includes a compromise of your own development, production, or maintenance environment where that compromise could increase cybersecurity risk for users, including malicious code injected into a build pipeline or a security-update channel. It does not require that any customer has actually been harmed. Being "capable of negatively affecting" is enough. So, teams that focus only on the US breach-notification standard, which usually requires unauthorized acquisition of data, may fail to meet reporting requirements under the CRA.
The Reporting Timeline
Reports are submitted through the European Union Agency for Cybersecurity's (ENISA's) CRA Single Reporting Platform to two recipients: the ENISA and the Computer Security Incident Response Team (CSIRT) that serves as the coordinator for the Member State of your main EU establishment. The platform went live on September 11.
Timeline for an actively exploited vulnerability:
* Early warning within 24 hours of becoming aware, identifying the Member States where the product has been made available.
* Vulnerability notification within 72 hours of becoming aware, covering the general nature of the vulnerability and of the exploit, an initial assessment, and any corrective or mitigating measures taken or available to users.
* Final report within 14 days after a corrective or mitigating measure becomes available, covering a description of the vulnerability, its severity and impact, information about the malicious actor where available, and details of the security update.
Timeline for a severe incident:
* Early warning within 24 hours of becoming aware, stating whether the incident is suspected to have been caused by unlawful or malicious acts and identifying the affected Member States.
* Incident notification within 72 hours of becoming aware, covering the nature of the incident and an initial assessment, including its severity and impact.
* Final report within one month of the 72-hour notification, covering a detailed description of the incident, the type of threat or root cause, and the mitigation measures applied and ongoing.
The 72-hour filing is mandatory for both categories, even if you submit a detailed 24-hour early warning.
Don't Forget to Notify Your Customers
After becoming aware of an actively exploited vulnerability or a severe incident, the manufacturer must inform impacted users, and, where appropriate, all users, about the vulnerability or incident and, when necessary, about risk mitigation and any corrective measures the user can deploy. Where appropriate, that information must be provided in a machine-readable format that is easily and automatically processable.
Be sure to review your CRA customer-notice obligations, because your existing customer agreements, confidentiality provisions, and other disclosure requirements may not fully address what the CRA requires. Public companies should also consider how the CRA's customer-notice requirements may interact with their disclosure obligations under SEC Item 1.05. You'll want to identify and address any gaps before an incident occurs.
Older Products May Still Be Subject to CRA Reporting
There's an important exception for older products. Although products placed on the EU market before December 11, 2027, are generally exempt from the CRA's broader product requirements, they are still subject to the new reporting rules. So, if you sold a covered product in the EU years ago, you may still have to report a newly discovered vulnerability or severe security incident involving that product.
What Noncompliance Costs
The reporting obligations are in the CRA's top enforcement tier, alongside breaches of the essential cybersecurity requirements. Maximum administrative fines are 15 million euros or 2.5% of total worldwide annual turnover for the preceding financial year, whichever is higher. Supplying incorrect, incomplete, or misleading information to notified bodies or market surveillance authorities carries a separate tier of up to 5 million euros or 1% of worldwide turnover. Member States set the actual penalties within those limits, and enforcement will vary.
What the CRA Will Require by December 2027
Products with digital elements must be designed, developed, and produced so that they deliver an appropriate level of cybersecurity based on the risks. Among other things, covered products must:
* not contain known exploitable vulnerabilities;
* be made available with a secure-by-default configuration, unless otherwise agreed between the manufacturer and a business user for a tailor-made product, including the ability to reset the product to its original state;
* ensure that vulnerabilities can be addressed through security updates, including automatic security updates enabled by default where applicable, with a clear opt-out mechanism, user notification of available updates, and the option to postpone them temporarily;
* protect against unauthorized access through appropriate control mechanisms, including authentication and identity or access management systems, and report possible unauthorized access;
* protect the confidentiality of stored, transmitted, or otherwise processed data;
* protect the integrity of stored, transmitted, or otherwise processed data;
* process only data that is adequate, relevant, and limited to what is necessary for the product's intended purpose;
* protect the availability of essential and basic functions, including after an incident, through resilience and mitigation measures against denial-of-service attacks;
* minimize the negative impact of the product or connected devices on the availability of services provided by other devices or networks;
* limit attack surfaces, including external interfaces;
* reduce the impact of an incident through appropriate exploitation mitigation mechanisms and techniques;
* provide security-related information by recording and monitoring relevant internal activity, including access to or modification of data, services, or functions, with a user opt-out; and
* allow users to securely and permanently remove all data and settings, and to transfer that data to other products or systems securely where transfer is supported.
Seven Steps to Consider Taking Now
1. Register on the Single Reporting Platform before an incident occurs. Onboarding is not something you can complete inside a 24-hour window. Each manufacturer will need to designate one Primary Assigned Representative who can then invite Secondary Assigned Representatives. Identify those people now and get them credentialed.
2. Identify your CSIRT coordinator now. Determine which Member State's CSIRT will serve as your coordinator and document your decision in writing. Generally, this will be based on where decisions about your products' cybersecurity are made. If you don't have an EU establishment, you'll need to consider other factors, including the location of your authorized representative, importers, distributors, and users. Make this determination now so you know where to report if a vulnerability or security incident occurs.
3. Create a clear process for deciding when a CRA report is required. Assign a decision-maker and a backup person to assess each of the following:
* whether a vulnerability is being actively exploited, and what evidence meets the "reliable evidence" threshold;
* whether an event meets the severe-incident definition, including the "capable of negatively affecting" aspect;
* which product versions, SKUs, and customers are affected, and in which Member States; and
* what corrective or mitigating measures are available or being developed, and when they will be available.
4. Add the CRA deadlines to your existing incident response plan. Identify who will determine whether a CRA report is required, who will prepare and approve the filing, and how the CRA's 24-hour, 72-hour, 14-day, and one-month deadlines fit with your other reporting obligations, such as GDPR, NIS2, SEC, HIPAA, and US state breach-notification laws. Then test the process with a tabletop exercise involving an incident that could trigger more than one reporting requirement.
5. Review your customer agreements for potential conflicts with the CRA. Identify notice deadlines, content restrictions, and confidentiality terms that may conflict with the CRA's requirements. Draft template customer notices now, including a machine-readable version, and have them reviewed before an incident occurs.
6. Start planning for the December 2027 deadlines now. Make sure your product inventory includes older products that may still be covered by the CRA, and determine how each product is classified under the law. Identify and address any gaps in your software bill of materials (SBOM) and coordinated vulnerability disclosure processes. If any of your products will require a conformity assessment by a notified body, start that process early.
7. Reach out to counsel with compliance questions. The CRA's requirements will vary depending on your products, where they are sold, and your role in the supply chain. Work with counsel to determine which requirements apply to your organization and address any compliance gaps before a vulnerability or security incident occurs.
* * *
Related People
Daniel Pepper, CIPP/US
Partner
dpepper@fisherphillips.com
303/218-3661
* * *
Jillian Seifrit, CIPP/US
Associate
jseifrit@fisherphillips.com
610/230-6129
* * *
Original text here: https://www.fisherphillips.com/en/insights/insights/eu-cyber-resilience-act-reporting-is-now-live
[Category: BizLaw/Legal]
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EU Cyber Resilience Act Reporting Is Now Live: A 7-Step Plan for Manufacturers Facing 24-Hour Deadlines
Sep 25, 2026
Manufacturers need to be aware of the European Union's cybersecurity law for products with digital elements. If your company sells a connected product, a software application, or a hardware component in the European Union, you are already on a 24-hour reporting clock. The EU Cyber Resilience Act's (CRA's) reporting requirements may apply even to products your company sold years ago, ... Show Full Article ATLANTA, Georgia, Sept. 26 -- Fisher Phillips, a law firm, issued the following Insight: * * * EU Cyber Resilience Act Reporting Is Now Live: A 7-Step Plan for Manufacturers Facing 24-Hour Deadlines Sep 25, 2026 Manufacturers need to be aware of the European Union's cybersecurity law for products with digital elements. If your company sells a connected product, a software application, or a hardware component in the European Union, you are already on a 24-hour reporting clock. The EU Cyber Resilience Act's (CRA's) reporting requirements may apply even to products your company sold years ago,and violations can trigger the law's highest penalties. Here's what manufacturers need to know about the reporting requirements that took effect September 11, which products are covered, and seven steps you should consider taking now to comply.
What the CRA Covers
The CRA establishes reporting obligations for actively exploited vulnerabilities and severe incidents. These requirements took effect on September 11, 2026, while the CRA's broader product-compliance regime does not apply until December 11, 2027. This cybersecurity law covers products with digital elements, which means software or hardware products and their remote data processing solutions, including software or hardware components placed on the market separately. The law's reach is broad, covering industrial controllers, connected consumer devices, operating systems, mobile applications, network equipment, and firmware.
Several categories, however, are not included because other EU regimes already govern their cybersecurity. Medical devices and in vitro diagnostics, type-approved motor vehicles, certified civil aviation equipment, and marine equipment are excluded. So are products developed or modified exclusively for national security or defense purposes, products designed to process classified information, and spare parts manufactured to the same specifications as the parts they replace.
Standalone software-as-a-service is generally outside the CRA. SaaS is captured only where it functions as a remote data processing solution, meaning remote processing that the manufacturer designs and develops and that the product could not perform its functions without. If your cloud service is the product rather than a component of a product, the CRA likely won't come into play, but NIS2 and DORA might.
Who Bears the Obligation
Manufacturers carry the reporting duty. A manufacturer is any natural or legal person that develops or manufactures products with digital elements, or has them designed, developed, or manufactured, and markets them under its own name or trademark, whether for payment, for monetization, or free of charge.
The product does not need to be created in the EU. Rather, the obligation is triggered when the product is placed on the EU market. A US company that sells into the EU through a distributor is a manufacturer under the CRA and must report. Manufacturers established outside the EU must also designate an authorized representative in the EU.
Importers and distributors do not file the reports themselves, but they do have some obligations. Both must inform the manufacturer without undue delay when becoming aware of a vulnerability in the product. Both must immediately inform the market surveillance authorities of the Member States where they made the product available if the product presents a significant cybersecurity risk.
An importer or distributor that markets a product under its own name or trademark, or that substantially modifies a product already on the market, becomes the manufacturer for CRA purposes and inherits the full reporting obligation. Be sure to carefully review private-label and white-label arrangements on this point.
Open-source software stewards are subject to a lighter, separate regime. The European Commission's stated position is that steward reporting obligations begin on December 11, 2027, not September 2026.
What Must Be Reported
The following two categories start the reporting clock:
* An actively exploited vulnerability, when there is reliable evidence that a malicious actor has exploited it in a system without the permission of the system owner. Good-faith security testing and coordinated disclosure without malicious intent do not trigger the duty.
* A severe incident that has an impact on the security of the product, meaning an incident that negatively affects or is capable of negatively affecting the product's ability to protect the availability, authenticity, integrity, or confidentiality of data or functions. It also covers an incident that has led or is capable of leading to the introduction or execution of malicious code in the product or in a user's network and information systems.
Importantly, a severe incident doesn't have to directly affect a customer. It includes a compromise of your own development, production, or maintenance environment where that compromise could increase cybersecurity risk for users, including malicious code injected into a build pipeline or a security-update channel. It does not require that any customer has actually been harmed. Being "capable of negatively affecting" is enough. So, teams that focus only on the US breach-notification standard, which usually requires unauthorized acquisition of data, may fail to meet reporting requirements under the CRA.
The Reporting Timeline
Reports are submitted through the European Union Agency for Cybersecurity's (ENISA's) CRA Single Reporting Platform to two recipients: the ENISA and the Computer Security Incident Response Team (CSIRT) that serves as the coordinator for the Member State of your main EU establishment. The platform went live on September 11.
Timeline for an actively exploited vulnerability:
* Early warning within 24 hours of becoming aware, identifying the Member States where the product has been made available.
* Vulnerability notification within 72 hours of becoming aware, covering the general nature of the vulnerability and of the exploit, an initial assessment, and any corrective or mitigating measures taken or available to users.
* Final report within 14 days after a corrective or mitigating measure becomes available, covering a description of the vulnerability, its severity and impact, information about the malicious actor where available, and details of the security update.
Timeline for a severe incident:
* Early warning within 24 hours of becoming aware, stating whether the incident is suspected to have been caused by unlawful or malicious acts and identifying the affected Member States.
* Incident notification within 72 hours of becoming aware, covering the nature of the incident and an initial assessment, including its severity and impact.
* Final report within one month of the 72-hour notification, covering a detailed description of the incident, the type of threat or root cause, and the mitigation measures applied and ongoing.
The 72-hour filing is mandatory for both categories, even if you submit a detailed 24-hour early warning.
Don't Forget to Notify Your Customers
After becoming aware of an actively exploited vulnerability or a severe incident, the manufacturer must inform impacted users, and, where appropriate, all users, about the vulnerability or incident and, when necessary, about risk mitigation and any corrective measures the user can deploy. Where appropriate, that information must be provided in a machine-readable format that is easily and automatically processable.
Be sure to review your CRA customer-notice obligations, because your existing customer agreements, confidentiality provisions, and other disclosure requirements may not fully address what the CRA requires. Public companies should also consider how the CRA's customer-notice requirements may interact with their disclosure obligations under SEC Item 1.05. You'll want to identify and address any gaps before an incident occurs.
Older Products May Still Be Subject to CRA Reporting
There's an important exception for older products. Although products placed on the EU market before December 11, 2027, are generally exempt from the CRA's broader product requirements, they are still subject to the new reporting rules. So, if you sold a covered product in the EU years ago, you may still have to report a newly discovered vulnerability or severe security incident involving that product.
What Noncompliance Costs
The reporting obligations are in the CRA's top enforcement tier, alongside breaches of the essential cybersecurity requirements. Maximum administrative fines are 15 million euros or 2.5% of total worldwide annual turnover for the preceding financial year, whichever is higher. Supplying incorrect, incomplete, or misleading information to notified bodies or market surveillance authorities carries a separate tier of up to 5 million euros or 1% of worldwide turnover. Member States set the actual penalties within those limits, and enforcement will vary.
What the CRA Will Require by December 2027
Products with digital elements must be designed, developed, and produced so that they deliver an appropriate level of cybersecurity based on the risks. Among other things, covered products must:
* not contain known exploitable vulnerabilities;
* be made available with a secure-by-default configuration, unless otherwise agreed between the manufacturer and a business user for a tailor-made product, including the ability to reset the product to its original state;
* ensure that vulnerabilities can be addressed through security updates, including automatic security updates enabled by default where applicable, with a clear opt-out mechanism, user notification of available updates, and the option to postpone them temporarily;
* protect against unauthorized access through appropriate control mechanisms, including authentication and identity or access management systems, and report possible unauthorized access;
* protect the confidentiality of stored, transmitted, or otherwise processed data;
* protect the integrity of stored, transmitted, or otherwise processed data;
* process only data that is adequate, relevant, and limited to what is necessary for the product's intended purpose;
* protect the availability of essential and basic functions, including after an incident, through resilience and mitigation measures against denial-of-service attacks;
* minimize the negative impact of the product or connected devices on the availability of services provided by other devices or networks;
* limit attack surfaces, including external interfaces;
* reduce the impact of an incident through appropriate exploitation mitigation mechanisms and techniques;
* provide security-related information by recording and monitoring relevant internal activity, including access to or modification of data, services, or functions, with a user opt-out; and
* allow users to securely and permanently remove all data and settings, and to transfer that data to other products or systems securely where transfer is supported.
Seven Steps to Consider Taking Now
1. Register on the Single Reporting Platform before an incident occurs. Onboarding is not something you can complete inside a 24-hour window. Each manufacturer will need to designate one Primary Assigned Representative who can then invite Secondary Assigned Representatives. Identify those people now and get them credentialed.
2. Identify your CSIRT coordinator now. Determine which Member State's CSIRT will serve as your coordinator and document your decision in writing. Generally, this will be based on where decisions about your products' cybersecurity are made. If you don't have an EU establishment, you'll need to consider other factors, including the location of your authorized representative, importers, distributors, and users. Make this determination now so you know where to report if a vulnerability or security incident occurs.
3. Create a clear process for deciding when a CRA report is required. Assign a decision-maker and a backup person to assess each of the following:
* whether a vulnerability is being actively exploited, and what evidence meets the "reliable evidence" threshold;
* whether an event meets the severe-incident definition, including the "capable of negatively affecting" aspect;
* which product versions, SKUs, and customers are affected, and in which Member States; and
* what corrective or mitigating measures are available or being developed, and when they will be available.
4. Add the CRA deadlines to your existing incident response plan. Identify who will determine whether a CRA report is required, who will prepare and approve the filing, and how the CRA's 24-hour, 72-hour, 14-day, and one-month deadlines fit with your other reporting obligations, such as GDPR, NIS2, SEC, HIPAA, and US state breach-notification laws. Then test the process with a tabletop exercise involving an incident that could trigger more than one reporting requirement.
5. Review your customer agreements for potential conflicts with the CRA. Identify notice deadlines, content restrictions, and confidentiality terms that may conflict with the CRA's requirements. Draft template customer notices now, including a machine-readable version, and have them reviewed before an incident occurs.
6. Start planning for the December 2027 deadlines now. Make sure your product inventory includes older products that may still be covered by the CRA, and determine how each product is classified under the law. Identify and address any gaps in your software bill of materials (SBOM) and coordinated vulnerability disclosure processes. If any of your products will require a conformity assessment by a notified body, start that process early.
7. Reach out to counsel with compliance questions. The CRA's requirements will vary depending on your products, where they are sold, and your role in the supply chain. Work with counsel to determine which requirements apply to your organization and address any compliance gaps before a vulnerability or security incident occurs.
* * *
Related People
Daniel Pepper, CIPP/US
Partner
dpepper@fisherphillips.com
303/218-3661
* * *
Jillian Seifrit, CIPP/US
Associate
jseifrit@fisherphillips.com
610/230-6129
* * *
Original text here: https://www.fisherphillips.com/en/insights/insights/eu-cyber-resilience-act-reporting-is-now-live
[Category: BizLaw/Legal]
AstraZeneca: Perioperative Imfinzi Plus Neoadjuvant Enfortumab Vedotin Granted Priority Review in the US for Patients With Muscle-invasive Bladder Cancer
WILMINGTON, Delaware, Sept. 26 -- AstraZeneca, a biopharmaceutical company, issued the following news release:
* * *
Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer
25 September 2026
Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival
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AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV) ... Show Full Article WILMINGTON, Delaware, Sept. 26 -- AstraZeneca, a biopharmaceutical company, issued the following news release: * * * Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer 25 September 2026 Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival - AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV)has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance./1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is anticipated during the fourth quarter of 2026.
Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumor invades the muscle wall of the bladder, without distant metastases./2,3 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities./4,5 The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis./4-6
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This Priority Review reinforces the potential of IMFINZI to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting."
The sBLA is based on results from the VOLGA Phase III trial, which will be presented at a forthcoming medical meeting. In a planned interim analysis, perioperative treatment with IMFINZI in combination with neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) versus radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.
The safety and tolerability of IMFINZI plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.
Regulatory applications are currently under review in the EU, Japan and several other countries based on the results of the VOLGA trial.
IMFINZI is approved in over 50 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. IMFINZI in combination with Bacillus Calmette-Guerin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naive, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial. In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.
IMPORTANT SAFETY INFORMATION
There are no contraindications for IMFINZI(R) (durvalumab) or IMJUDO(R) (tremelimumab-actl).
Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
* IMFINZI as a Single Agent
- In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.
- In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.
- The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.
- The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
* IMFINZI with IMJUDO
- Immune mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
Immune-Mediated Colitis
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
* IMFINZI as a Single Agent
- Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.
Immune-Mediated Hepatitis
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.
* IMFINZI as a Single Agent
- Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.
Immune-Mediated Endocrinopathies
* Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
* Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
- IMFINZI with IMJUDO
= Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
* Thyroid Disorders: IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
= Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
= Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.
= Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.
= Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
- IMFINZI with Carboplatin and Paclitaxel
= Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
* Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
- IMFINZI with IMJUDO
= Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI and IMJUDO can cause immune-mediated nephritis.
* IMFINZI as a Single Agent
- Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-Mediated Dermatology Reactions
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
* IMFINZI as a Single Agent
- Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.
* Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
* Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.
* Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
* Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
* Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
* Endocrine: Hypoparathyroidism.
* Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.
* Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
* IMFINZI as a Single Agent
- Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
* IMFINZI with IMJUDO
- Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.
Lactation
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.
Adverse Reactions
Unresectable Stage III NSCLC
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.
Resectable NSCLC
* In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in 20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
* In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.
* In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.
Metastatic NSCLC
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in 20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.
Limited-stage Small Cell Lung Cancer
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in 20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonitis or radiation pneumonitis and pneumonia.
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in 1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).
Extensive-stage Small Cell Lung Cancer
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (3%) was fatigue/asthenia (3.4%).
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.
Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in 20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).
Unresectable Hepatocellular Carcinoma (HCC)
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in 20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.
Primary Advanced or Recurrent dMMR Endometrial Cancer
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (3%) were constipation (4.5%) and fatigue (4.5%).
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (4%) were constipation (4.5%) and rash (4.5%).
BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).
Muscle-Invasive Bladder Cancer (MIBC)
* In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in 20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.
* In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.
* In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in 1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).
Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)
* In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in 20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
* In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of 2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of 2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of 2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.
Indications:
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.
IMFINZI in combination with Bacillus Calmette-Guerin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Please see Full Prescribing Information including Medication Guide for IMFINZI (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9496217c-08b3-432b-ab4f-538d795820bd/9496217c-08b3-432b-ab4f-538d795820bd_viewable_rendition__v.pdf) and IMJUDO (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/0102c6fd-de8a-4b43-afa3-2a2c2115d472/0102c6fd-de8a-4b43-afa3-2a2c2115d472_viewable_rendition__v.pdf).
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Notes
Bladder cancer
Bladder cancer is the 8th most common cancer in the world, with more than 635,000 cases diagnosed each year.7 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.8
In 2026, around 15,000 patients will be treated for MIBC in the United States.9 In 2025, the NIAGARA Phase III trial established a new standard of care by adding perioperative IMFINZI to neoadjuvant cisplatin-based chemotherapy and radical cystectomy.10 However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence.4,6 New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.
VOLGA
VOLGA is a Phase III, randomized, open-label, multi-center global trial evaluating perioperative IMFINZI with or without IMJUDO in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are not eligible for or have declined cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomized 1:1:1 to Arm 1 (three cycles of IMFINZI and EV, plus two cycles of IMJUDO prior to surgery, followed by nine cycles of IMFINZI plus one cycle of IMJUDO as adjuvant therapy), Arm 2 (three cycles of IMFINZI and EV prior to surgery, followed by nine cycles of IMFINZI adjuvant monotherapy) and Arm 3, the comparator arm.
The trial was conducted in 182 centers across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomization to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.
IMFINZI(R) (durvalumab)
IMFINZI(R) (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
In addition to its bladder cancer indications, IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO(R) (tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC. IMFINZI is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.
IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US, EU and Japan. Additionally, in April 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone for patients with unresectable HCC eligible for embolization in the EMERALD-3 Phase III trial.
IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US, EU and China). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.
Since the first approval in May 2017, more than 470,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.
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AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body's immune system to attack tumors.
AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
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AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
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AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.
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References
1. FDA. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed September 2026.
2. Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer. Eur Urol. 2013;63(2):234-241.
3. National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289/. Accessed September 2026.
4. Dash A, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506-513.
5. Galsky MD, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.
6. Holzbeierlein J, Bixler BR, Buckley DI, Chang SS, Holmes RS, James AC, et al. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO Guideline (2017; Amended 2020, 2024). J Urology [Internet]. 2024 Jul 1 [cited 2026 Sep 3];212(1):3-10. Available from: https://doi.org/10.1097/JU.0000000000003981.
7. World Health Organization. International Agency for Research on Cancer. Bladder Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. Accessed September 2026.
8. American Cancer Society. What Is Bladder Cancer? Available at: https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html. Accessed September 2026.
9. AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed September 2026.
10. AstraZeneca PLC. Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html. Accessed September 2026.
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Original text here: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Perioperative-IMFINZI-durvalumab-plus-neoadjuvant-enfortumab-vedotin-granted-Priority-Review-in-the-US-for-patients-with-muscle-invasive-bladder-cancer.html
[Category: BizPharmaceuticals]
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Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer
25 September 2026
Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival
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AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV) ... Show Full Article WILMINGTON, Delaware, Sept. 26 -- AstraZeneca, a biopharmaceutical company, issued the following news release: * * * Perioperative IMFINZI(R) (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer 25 September 2026 Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival - AstraZeneca's supplemental Biologics License Application (sBLA) for IMFINZI(R) (durvalumab) in combination with enfortumab vedotin (EV)has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance./1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is anticipated during the fourth quarter of 2026.
Approximately one in four patients with bladder cancer has muscle-invasive disease, where the tumor invades the muscle wall of the bladder, without distant metastases./2,3 As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities./4,5 The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis./4-6
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This Priority Review reinforces the potential of IMFINZI to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting."
The sBLA is based on results from the VOLGA Phase III trial, which will be presented at a forthcoming medical meeting. In a planned interim analysis, perioperative treatment with IMFINZI in combination with neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) versus radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment.
The safety and tolerability of IMFINZI plus EV was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.
Regulatory applications are currently under review in the EU, Japan and several other countries based on the results of the VOLGA trial.
IMFINZI is approved in over 50 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. IMFINZI in combination with Bacillus Calmette-Guerin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naive, high-risk non-muscle-invasive bladder cancer, based on the POTOMAC Phase III trial. In July 2026, positive high-level results from the NILE Phase III trial showed IMFINZI plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS versus chemotherapy as 1st-line treatment for patients with PD-L1 high unresectable, locally advanced or metastatic urothelial cancer.
IMPORTANT SAFETY INFORMATION
There are no contraindications for IMFINZI(R) (durvalumab) or IMJUDO(R) (tremelimumab-actl).
Severe and Fatal Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.
* IMFINZI as a Single Agent
- In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions.
- In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions.
- The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions.
- The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy.
* IMFINZI with IMJUDO
- Immune mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions.
Immune-Mediated Colitis
IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
* IMFINZI as a Single Agent
- Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients.
Immune-Mediated Hepatitis
IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal.
* IMFINZI as a Single Agent
- Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions.
Immune-Mediated Endocrinopathies
* Adrenal Insufficiency: IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions.
* Hypophysitis: IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
- IMFINZI with IMJUDO
= Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
* Thyroid Disorders: IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
- IMFINZI as a Single Agent
= Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
= Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
= Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
- IMFINZI with IMJUDO
= Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO.
= Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy.
= Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
= Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions.
- IMFINZI with Carboplatin and Paclitaxel
= Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel.
* Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated.
- IMFINZI as a Single Agent
= Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
- IMFINZI with IMJUDO
= Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up.
- IMFINZI with IMJUDO and Platinum-Based Chemotherapy
= Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI and IMJUDO can cause immune-mediated nephritis.
* IMFINZI as a Single Agent
- Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions.
Immune-Mediated Dermatology Reactions
IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
* IMFINZI as a Single Agent
- Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
* IMFINZI with IMJUDO
- Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Immune-Mediated Pancreatitis
IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions.
Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors.
* Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
* Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy.
* Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
* Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
* Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
* Endocrine: Hypoparathyroidism.
* Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.
* Other: Myocarditis-Myositis-Myasthenia Gravis (or Myasthenia-Like) Overlap Syndrome, reported as the co-occurrence of either two or all three adverse reactions
Infusion-Related Reactions
IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. See USPI Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.
* IMFINZI as a Single Agent
- Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
* IMFINZI with IMJUDO
- Infusion-related reactions occurred in 2.6% (10/388) of patients receiving IMFINZI and IMJUDO.
* IMFINZI with IMJUDO and Platinum-Based Chemotherapy
- Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO.
Lactation
There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose.
Adverse Reactions
Unresectable Stage III NSCLC
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%).
* In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms.
Resectable NSCLC
* In patients with resectable NSCLC in the AEGEAN study, the most common adverse reactions (occurring in 20% of patients) were anemia, nausea, constipation, fatigue, musculoskeletal pain, and rash.
* In patients with resectable NSCLC in the neoadjuvant phase of the AEGEAN study receiving IMFINZI in combination with platinum-containing chemotherapy (n=401), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6.7% of patients. Serious adverse reactions occurred in 21% of patients. The most frequent (1%) serious adverse reactions were pneumonia (2.7%), anemia (1.5%), myelosuppression (1.5%), vomiting (1.2%), neutropenia (1%), and acute kidney injury (1%). Fatal adverse reactions occurred in 2% of patients, including death due to COVID-19 pneumonia (0.5%), sepsis (0.5%), myocarditis (0.2%), decreased appetite (0.2%), hemoptysis (0.2%), and death not otherwise specified (0.2%). Of the 401 IMFINZI-treated patients who received neoadjuvant treatment and 398 placebo-treated patients who received neoadjuvant treatment, 1.7% (n=7) and 1% (n=4), respectively, did not receive surgery due to adverse reactions.
* In patients with resectable NSCLC in the adjuvant phase of the AEGEAN study receiving IMFINZI as a single agent (n=265), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 8% of patients. Serious adverse reactions occurred in 13% of patients. The most frequent serious adverse reactions reported in >1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm.
Metastatic NSCLC
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in 20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%).
* In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients.
Limited-stage Small Cell Lung Cancer
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in 20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). The most common Grade 3 or 4 adverse reactions (3%) were pneumonitis or radiation pneumonitis and pneumonia.
* In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), IMFINZI was permanently discontinued due to adverse reactions in 16% of the patients receiving IMFINZI. Serious adverse reactions occurred in 30% of patients receiving IMFINZI. The most frequent serious adverse reactions reported in 1% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (12%), and pneumonia (5%). Fatal adverse reactions occurred in 2.7% of patients who received IMFINZI including pneumonia (1.5%), cardiac failure, encephalopathy and pneumonitis (0.4% each).
Extensive-stage Small Cell Lung Cancer
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (3%) was fatigue/asthenia (3.4%).
* In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy.
Locally Advanced or Metastatic Biliary Tract Cancers (BTCs)
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in 20% of patients) were fatigue (42%), nausea (40%), constipation (32%), decreased appetite (26%), abdominal pain (24%), rash (23%), and pyrexia (20%).
* In patients with locally advanced or metastatic BTCs in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%), and acute kidney injury (2.4%). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients).
Unresectable Hepatocellular Carcinoma (HCC)
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), the most common adverse reactions (occurring in 20% of patients) were rash (32%), diarrhea (27%), fatigue (26%), pruritus (23%), musculoskeletal pain (22%), and abdominal pain (20%).
* In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO (n=388), serious adverse reactions occurred in 41% of patients. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Fatal adverse reactions occurred in 8% of patients who received IMFINZI and IMJUDO, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients.
Primary Advanced or Recurrent dMMR Endometrial Cancer
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), the most common adverse reactions, including laboratory abnormalities (occurring in >20% of patients) were peripheral neuropathy (61%), musculoskeletal pain (59%), nausea (59%), alopecia (52%), fatigue (41%), abdominal pain (39%), constipation (39%), rash (39%), decreased magnesium (36%), increased ALT (32%), increased AST (30%), diarrhea (27%), vomiting (27%), cough (27%), decreased potassium (25%), dyspnea (25%), headache (23%), increased alkaline phosphatase (20%), and decreased appetite (18%). The most common Grade 3 or 4 adverse reactions (3%) were constipation (4.5%) and fatigue (4.5%).
* In patients with primary advanced or recurrent dMMR endometrial cancer in the DUO-E study receiving IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent (n=44), permanent discontinuation of IMFINZI due to adverse reactions occurred in 11% of patients. Serious adverse reactions occurred in 30% of patients who received IMFINZI with carboplatin and paclitaxel; the most common serious adverse reactions (4%) were constipation (4.5%) and rash (4.5%).
BCG-Naive, High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, the most common (20%) adverse reactions, including laboratory abnormalities were increased glucose (43%), increased AST (43%), increased lipase (42%), increased ALT (42%), increased GGT (40%), urinary tract infection (40%), increased potassium (39%), dysuria (37%), decreased hemoglobin (35%), hematuria (33%), increased serum creatinine (30%), musculoskeletal pain (28%), decreased lymphocytes (27%), urinary frequency (26%), decreased sodium (23%), fatigue (21%), rash (20%), and pyrexia (20%).
* In patients with BCG-naive, HR-NMIBC in the POTOMAC study receiving IMFINZI in combination with BCG, permanent discontinuation of IMFINZI due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of IMFINZI (1%) were hepatitis (1.8%), acute kidney injury (1.2%), and diarrhea (1.2%). Serious adverse reactions occurred in 32% of patients. The most common (1%) serious adverse reactions were urinary tract infection (4.5%), COVID (1.8%), hepatitis (1.5%), dysuria (1.2%), and prostate cancer (1.2%). Fatal adverse reactions occurred in 2.4% of patients who received IMFINZI in combination with BCG, including congestive cardiac failure (0.6%), COVID (0.3%), cardiovascular disorder (0.3%), dementia with Lewy bodies (0.3%), and pancreatic cancer (0.3%).
Muscle-Invasive Bladder Cancer (MIBC)
* In patients with MIBC, the most common adverse reactions, including laboratory abnormalities, in the overall study (occurring in 20% of patients) were decreased hemoglobin, decreased neutrophils, increased blood creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphatase, rash, pyrexia, diarrhea, vomiting and abdominal pain.
* In patients with MIBC in the neoadjuvant phase of the NIAGARA study receiving IMFINZI in combination with gemcitabine and cisplatin (n=530), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 9% of patients. Serious adverse reactions occurred in 24% of patients; the most frequent (1%) serious adverse reactions were pulmonary embolism (1.9%), febrile neutropenia (1.5%), acute kidney injury (1.3%), thrombocytopenia (1.3%), urinary tract infection (1.3%), and pneumonia (1.3%). Fatal adverse reactions occurred in 1.1% of patients including sepsis, myocardial infarction, and pulmonary embolism (0.2% each). One fatal adverse reaction of pneumonia was reported in 1 (0.2%) patient in the post-surgery phase before adjuvant treatment started. Of the 530 patients in the IMFINZI treatment arm and 526 patients in the chemotherapy treatment arm who received neoadjuvant treatment, 1 (0.2%) patient in each treatment arm did not receive surgery due to adverse reactions. The adverse reaction that led to cancellation of surgery in the IMFINZI treatment arm was interstitial lung disease.
* In patients with MIBC in the adjuvant phase of the NIAGARA study receiving IMFINZI as a single agent (n=383), permanent discontinuation of adjuvant IMFINZI due to an adverse reaction occurred in 5% of patients. Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions (occurring in 1% of patients) were urinary tract infection (7%), acute kidney injury (3.7%), hydronephrosis (2.1%), pyelonephritis (2.1%), urosepsis (1.8%) and sepsis (1.6%). Fatal adverse reactions occurred in 1.8% of patients, including COVID-19, severe acute respiratory syndrome, cardiopulmonary failure, gastrointestinal hemorrhage, and chronic hepatic failure (0.3% each).
Resectable Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJC)
* In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in 20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
* In patients with resectable GC/GEJC in the neoadjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=475), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 2.5% of patients. Serious adverse reactions occurred in 21% of patients; the most frequent (2%) serious adverse reaction was diarrhea (2.5%). Deaths occurred in 1.9% of patients; deaths of 2 patients included septic shock (0.6%) and acute coronary syndrome (0.4%). Of the 475 patients in the IMFINZI + FLOT chemotherapy treatment arm and 469 patients in the placebo + FLOT chemotherapy treatment arm who received neoadjuvant treatment, 0.6% and 0.4% of patients, respectively, did not receive surgery due to adverse reactions, and 2.3% and 2.6% of patients, respectively, had a delay in surgery due to ARs.
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI in combination with FLOT chemotherapy (n=365), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 7% of patients. Serious adverse reactions occurred in 29% of patients; the most frequent (2%) serious adverse reaction was pneumonia (2.5%). Deaths occurred in 2.2% of patients; deaths of 2 patients included gastrointestinal perforation (0.5%) and COVID-19 (0.5%).
* In patients with resectable GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone (n=345), permanent discontinuation of IMFINZI due to an adverse reaction occurred in 6% of patients. Serious adverse reactions occurred in 14% of patients. Deaths occurred in 1.7% of patients; deaths of 2 patients included gastrointestinal perforation (0.6%) and COVID-19 (0.6%).
The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients.
Indications:
IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients with resectable (tumors 4 cm and/or node positive) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT).
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC).
IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC).
IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-authorized test.
IMFINZI in combination with Bacillus Calmette-Guerin (BCG) is indicated for the treatment of adult patients with BCG-naive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Please see Full Prescribing Information including Medication Guide for IMFINZI (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/9496217c-08b3-432b-ab4f-538d795820bd/9496217c-08b3-432b-ab4f-538d795820bd_viewable_rendition__v.pdf) and IMJUDO (https://drd9vrdh9yh09.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/0102c6fd-de8a-4b43-afa3-2a2c2115d472/0102c6fd-de8a-4b43-afa3-2a2c2115d472_viewable_rendition__v.pdf).
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Notes
Bladder cancer
Bladder cancer is the 8th most common cancer in the world, with more than 635,000 cases diagnosed each year.7 The most common type is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.8
In 2026, around 15,000 patients will be treated for MIBC in the United States.9 In 2025, the NIAGARA Phase III trial established a new standard of care by adding perioperative IMFINZI to neoadjuvant cisplatin-based chemotherapy and radical cystectomy.10 However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence.4,6 New treatment options that prevent both progression before surgery and recurrence after surgery are critically needed in this curative-intent setting.
VOLGA
VOLGA is a Phase III, randomized, open-label, multi-center global trial evaluating perioperative IMFINZI with or without IMJUDO in combination with neoadjuvant EV as treatment for patients with MIBC undergoing radical cystectomy who are not eligible for or have declined cisplatin compared to radical cystectomy with or without approved adjuvant therapy. In the trial, 695 patients were randomized 1:1:1 to Arm 1 (three cycles of IMFINZI and EV, plus two cycles of IMJUDO prior to surgery, followed by nine cycles of IMFINZI plus one cycle of IMJUDO as adjuvant therapy), Arm 2 (three cycles of IMFINZI and EV prior to surgery, followed by nine cycles of IMFINZI adjuvant monotherapy) and Arm 3, the comparator arm.
The trial was conducted in 182 centers across 25 countries in Europe, North America, South America and Asia. Its dual primary endpoints are EFS, defined as the time from randomization to first recurrence post-radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease or death due to any cause, for both experimental arms versus the comparator arm. Secondary endpoints include OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.
IMFINZI(R) (durvalumab)
IMFINZI(R) (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
In addition to its bladder cancer indications, IMFINZI is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, IMFINZI is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of IMJUDO(R) (tremelimumab-actl) and chemotherapy for the treatment of metastatic NSCLC. IMFINZI is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC.
IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with IMJUDO in unresectable hepatocellular carcinoma (HCC). It is also approved as a monotherapy in unresectable HCC in Japan, China and the EU, and in resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers in the US, EU and Japan. Additionally, in April 2026, IMFINZI in combination with IMJUDO, lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS versus TACE alone for patients with unresectable HCC eligible for embolization in the EMERALD-3 Phase III trial.
IMFINZI in combination with chemotherapy followed by IMFINZI monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US, EU and China). IMFINZI in combination with chemotherapy followed by olaparib and IMFINZI is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan.
Since the first approval in May 2017, more than 470,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.
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AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body's immune system to attack tumors.
AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZI as a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
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AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
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AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.
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References
1. FDA. Priority Review. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed September 2026.
2. Burger M, et al. Epidemiology and Risk Factors of Urothelial Bladder Cancer. Eur Urol. 2013;63(2):234-241.
3. National Collaborating Centre for Cancer. Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE). Available at: https://www.ncbi.nlm.nih.gov/books/NBK356289/. Accessed September 2026.
4. Dash A, et al. Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer. 2006;107(3):506-513.
5. Galsky MD, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.
6. Holzbeierlein J, Bixler BR, Buckley DI, Chang SS, Holmes RS, James AC, et al. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO Guideline (2017; Amended 2020, 2024). J Urology [Internet]. 2024 Jul 1 [cited 2026 Sep 3];212(1):3-10. Available from: https://doi.org/10.1097/JU.0000000000003981.
7. World Health Organization. International Agency for Research on Cancer. Bladder Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. Accessed September 2026.
8. American Cancer Society. What Is Bladder Cancer? Available at: https://www.cancer.org/cancer/types/bladder-cancer/about/what-is-bladder-cancer.html. Accessed September 2026.
9. AstraZeneca PLC. Investor relations epidemiology spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed September 2026.
10. AstraZeneca PLC. Imfinzi approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html. Accessed September 2026.
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Original text here: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Perioperative-IMFINZI-durvalumab-plus-neoadjuvant-enfortumab-vedotin-granted-Priority-Review-in-the-US-for-patients-with-muscle-invasive-bladder-cancer.html
[Category: BizPharmaceuticals]
Asian Legal Business Honors Morgan Lewis in 2026 M&A Rankings
PHILADELPHIA, Pennsylvania, Sept. 26 -- Morgan Lewis, a law firm, issued the following news release:
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Asian Legal Business Honors Morgan Lewis in 2026 M&A Rankings
SINGAPORE, HONG KONG, BEIJING, SHANGHAI, and TOKYO, September 25, 2026: Morgan Lewis has been recognized among the leading firms in the region by Asian Legal Business in its 2026 M&A rankings.
The annual rankings are based on the volume, complexity, and size of work undertaken and the firm's presence across Asia and in individual jurisdictions.
PRACTICE RANKINGS
* Singapore Domestic - Tier 2
* China International - Tier ... Show Full Article PHILADELPHIA, Pennsylvania, Sept. 26 -- Morgan Lewis, a law firm, issued the following news release: * * * Asian Legal Business Honors Morgan Lewis in 2026 M&A Rankings SINGAPORE, HONG KONG, BEIJING, SHANGHAI, and TOKYO, September 25, 2026: Morgan Lewis has been recognized among the leading firms in the region by Asian Legal Business in its 2026 M&A rankings. The annual rankings are based on the volume, complexity, and size of work undertaken and the firm's presence across Asia and in individual jurisdictions. PRACTICE RANKINGS * Singapore Domestic - Tier 2 * China International - Tier3
* Japan International - Tier 3
* Hong Kong - Notable Firm
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Original text here: https://www.morganlewis.com/news/2026/09/asian-legal-business-honors-morgan-lewis-in-2026-ma-rankings
[Category: BizLaw/Legal]
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Asian Legal Business Honors Morgan Lewis in 2026 M&A Rankings
SINGAPORE, HONG KONG, BEIJING, SHANGHAI, and TOKYO, September 25, 2026: Morgan Lewis has been recognized among the leading firms in the region by Asian Legal Business in its 2026 M&A rankings.
The annual rankings are based on the volume, complexity, and size of work undertaken and the firm's presence across Asia and in individual jurisdictions.
PRACTICE RANKINGS
* Singapore Domestic - Tier 2
* China International - Tier ... Show Full Article PHILADELPHIA, Pennsylvania, Sept. 26 -- Morgan Lewis, a law firm, issued the following news release: * * * Asian Legal Business Honors Morgan Lewis in 2026 M&A Rankings SINGAPORE, HONG KONG, BEIJING, SHANGHAI, and TOKYO, September 25, 2026: Morgan Lewis has been recognized among the leading firms in the region by Asian Legal Business in its 2026 M&A rankings. The annual rankings are based on the volume, complexity, and size of work undertaken and the firm's presence across Asia and in individual jurisdictions. PRACTICE RANKINGS * Singapore Domestic - Tier 2 * China International - Tier3
* Japan International - Tier 3
* Hong Kong - Notable Firm
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Original text here: https://www.morganlewis.com/news/2026/09/asian-legal-business-honors-morgan-lewis-in-2026-ma-rankings
[Category: BizLaw/Legal]