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Luck Stone Builds on Autonomous Hauling Success With Caterpillar
PEORIA, Illinois, Sept. 16 -- Caterpillar Inc., a manufacturer of construction and mining equipment, issued the following news release:
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Luck Stone Builds on Autonomous Hauling Success with Caterpillar
* More than 3.5 million tons hauled autonomously in 18-month pilot drives expansion to two additional Luck Stone quarries to enhance safety, consistency and new opportunities for associates.
* Quarry automation gains momentum with first-ever deployment of autonomous haulage solution on a Cat(R) 775
IRVING, Texas, Sept. 14, 2026 - Following more than 18 months of successful autonomous hauling ... Show Full Article PEORIA, Illinois, Sept. 16 -- Caterpillar Inc., a manufacturer of construction and mining equipment, issued the following news release: * * * Luck Stone Builds on Autonomous Hauling Success with Caterpillar * More than 3.5 million tons hauled autonomously in 18-month pilot drives expansion to two additional Luck Stone quarries to enhance safety, consistency and new opportunities for associates. * Quarry automation gains momentum with first-ever deployment of autonomous haulage solution on a Cat(R) 775 IRVING, Texas, Sept. 14, 2026 - Following more than 18 months of successful autonomous haulingat Luck Stone's Bull Run Quarry, Luck Stone and Caterpillar (NYSE: CAT) are expanding the technology to two additional Virginia operations. The expansion builds on proven results at Bull Run, where autonomous trucks have hauled more than 3.5 million tocans since going live in November 2024.
Collaborating to Solve Real-World Quarry Challenges
Quarry and aggregates producers across the industry face persistent operational challenges: maintaining consistent production across shifts, improving safety and attracting and developing talent in a competitive environment. For Luck Stone, technology is most valuable when it helps associates become the best versions of themselves while creating safer, more consistent operations. That's why Luck Stone sought a partner whose approach to autonomy puts people at the center of innovation.
Through close collaboration in development and implementation, Luck Stone has seen firsthand how Caterpillar's approach to combine technology, people and process can improve safety, increase production consistency and create new opportunities for associates to develop new skills and grow into technology-focused roles.
"At Luck Stone, we've always believed innovation should ignite human potential," said Travis Chewning, Luck Stone vice president of engineering & operations support. "Autonomy is creating a safer workplace that improves consistency for our customers and gives our associates opportunities to develop new skills as our industry continues to evolve. Our collaboration with Caterpillar has helped us do exactly that, and we're excited to continue building on what we've learned at Bull Run."
"Our mission at Caterpillar is to solve our customers' toughest challenges, and customers like Luck Stone play an important role in helping us advance solutions for the broader industry," said Denise Johnson, Caterpillar group president, Resource Industries. "By working together, we've gained insights that help us refine and scale autonomous hauling solutions that create measurable value for both operations and workforce development. This expansion demonstrates how strong customer collaborations are helping us accelerate innovation and bring proven solutions to more jobsites around the world."
Delivered by Caterpillar and supported by local Cat(R) dealer Carter Machinery, the expansion will integrate Caterpillar's autonomous hauling technology across two fleets of Cat(R) 775 trucks at Boscobel and Bealeton, alongside complementary technologies that support loaders and other site equipment. This marks the first time Caterpillar will deploy its autonomous haulage solution on the Cat 775, a key haul truck model in the quarry industry.
The Luck Stone expansion is the latest milestone in Caterpillar's growing momentum in quarry autonomy. Collectively, Caterpillar autonomous trucks have hauled more than 13 billion tonnes and safely traveled more than 455 million kilometers with no reported injuries while operating.
More information on Cat MineStar(TM) Command for hauling can be found by contacting a Cat dealer or visiting cat.com.
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URL: About Luck Stone
Through four generations of family leadership, Luck Stone has been building strong communities for over 100 years. Luck Stone, a division of Luck Companies, is the nation's largest family-owned and operated producer of crushed stone, sand and gravel. A responsive and creative partner to the construction, civil engineering and environmental industries, Luck Stone provides consistent, quality aggregate materials and services that serve as the foundation of roads, bridges and buildings.
Driven by our values of Integrity, Commitment, Leadership and Creativity, we believe in providing our associates with the tools and support to perform and lead at their best so they can ignite the potential in themselves and others. Our company is a community of people, utilizing the power of values and customer inspired relationships to redefine what's possible for an industry and make a positive and enduring impact. Luck Companies is headquartered in Richmond, Virginia, where it was founded by Charles Luck Jr. in 1923. Charlie Luck IV and Richard Luck lead the company today.
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About Caterpillar
For more than a century, Caterpillar has built a better, more sustainable world. With 2025 sales and revenues of $64.8 billion, Caterpillar Inc. is the world's leading manufacturer of construction and mining equipment, off-highway diesel and natural gas engines, industrial gas turbines and diesel-electric locomotives. The company principally operates through three primary segments -- Construction Industries, Resource Industries, and Energy & Transportation -- and provides financing and related services through its Financial Products segment. For more information, visit www.caterpillar.com.
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Original text here: https://www.caterpillar.com/en/news/corporate-press-releases/h/luck-stone-builds-on-autonomous-hauling-success-with-caterpillar.html
[Category: BizIndustrial Materials]
* * *
Luck Stone Builds on Autonomous Hauling Success with Caterpillar
* More than 3.5 million tons hauled autonomously in 18-month pilot drives expansion to two additional Luck Stone quarries to enhance safety, consistency and new opportunities for associates.
* Quarry automation gains momentum with first-ever deployment of autonomous haulage solution on a Cat(R) 775
IRVING, Texas, Sept. 14, 2026 - Following more than 18 months of successful autonomous hauling ... Show Full Article PEORIA, Illinois, Sept. 16 -- Caterpillar Inc., a manufacturer of construction and mining equipment, issued the following news release: * * * Luck Stone Builds on Autonomous Hauling Success with Caterpillar * More than 3.5 million tons hauled autonomously in 18-month pilot drives expansion to two additional Luck Stone quarries to enhance safety, consistency and new opportunities for associates. * Quarry automation gains momentum with first-ever deployment of autonomous haulage solution on a Cat(R) 775 IRVING, Texas, Sept. 14, 2026 - Following more than 18 months of successful autonomous haulingat Luck Stone's Bull Run Quarry, Luck Stone and Caterpillar (NYSE: CAT) are expanding the technology to two additional Virginia operations. The expansion builds on proven results at Bull Run, where autonomous trucks have hauled more than 3.5 million tocans since going live in November 2024.
Collaborating to Solve Real-World Quarry Challenges
Quarry and aggregates producers across the industry face persistent operational challenges: maintaining consistent production across shifts, improving safety and attracting and developing talent in a competitive environment. For Luck Stone, technology is most valuable when it helps associates become the best versions of themselves while creating safer, more consistent operations. That's why Luck Stone sought a partner whose approach to autonomy puts people at the center of innovation.
Through close collaboration in development and implementation, Luck Stone has seen firsthand how Caterpillar's approach to combine technology, people and process can improve safety, increase production consistency and create new opportunities for associates to develop new skills and grow into technology-focused roles.
"At Luck Stone, we've always believed innovation should ignite human potential," said Travis Chewning, Luck Stone vice president of engineering & operations support. "Autonomy is creating a safer workplace that improves consistency for our customers and gives our associates opportunities to develop new skills as our industry continues to evolve. Our collaboration with Caterpillar has helped us do exactly that, and we're excited to continue building on what we've learned at Bull Run."
"Our mission at Caterpillar is to solve our customers' toughest challenges, and customers like Luck Stone play an important role in helping us advance solutions for the broader industry," said Denise Johnson, Caterpillar group president, Resource Industries. "By working together, we've gained insights that help us refine and scale autonomous hauling solutions that create measurable value for both operations and workforce development. This expansion demonstrates how strong customer collaborations are helping us accelerate innovation and bring proven solutions to more jobsites around the world."
Delivered by Caterpillar and supported by local Cat(R) dealer Carter Machinery, the expansion will integrate Caterpillar's autonomous hauling technology across two fleets of Cat(R) 775 trucks at Boscobel and Bealeton, alongside complementary technologies that support loaders and other site equipment. This marks the first time Caterpillar will deploy its autonomous haulage solution on the Cat 775, a key haul truck model in the quarry industry.
The Luck Stone expansion is the latest milestone in Caterpillar's growing momentum in quarry autonomy. Collectively, Caterpillar autonomous trucks have hauled more than 13 billion tonnes and safely traveled more than 455 million kilometers with no reported injuries while operating.
More information on Cat MineStar(TM) Command for hauling can be found by contacting a Cat dealer or visiting cat.com.
* * *
URL: About Luck Stone
Through four generations of family leadership, Luck Stone has been building strong communities for over 100 years. Luck Stone, a division of Luck Companies, is the nation's largest family-owned and operated producer of crushed stone, sand and gravel. A responsive and creative partner to the construction, civil engineering and environmental industries, Luck Stone provides consistent, quality aggregate materials and services that serve as the foundation of roads, bridges and buildings.
Driven by our values of Integrity, Commitment, Leadership and Creativity, we believe in providing our associates with the tools and support to perform and lead at their best so they can ignite the potential in themselves and others. Our company is a community of people, utilizing the power of values and customer inspired relationships to redefine what's possible for an industry and make a positive and enduring impact. Luck Companies is headquartered in Richmond, Virginia, where it was founded by Charles Luck Jr. in 1923. Charlie Luck IV and Richard Luck lead the company today.
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About Caterpillar
For more than a century, Caterpillar has built a better, more sustainable world. With 2025 sales and revenues of $64.8 billion, Caterpillar Inc. is the world's leading manufacturer of construction and mining equipment, off-highway diesel and natural gas engines, industrial gas turbines and diesel-electric locomotives. The company principally operates through three primary segments -- Construction Industries, Resource Industries, and Energy & Transportation -- and provides financing and related services through its Financial Products segment. For more information, visit www.caterpillar.com.
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Original text here: https://www.caterpillar.com/en/news/corporate-press-releases/h/luck-stone-builds-on-autonomous-hauling-success-with-caterpillar.html
[Category: BizIndustrial Materials]
Johnson & Johnson: Rybrevant Faspro Plus Lazcluze With Prophylactic Strategies Shows Low Rates of Treatment-related Events at WCLC 2026
RARITAN, New Jersey, Sept. 16 -- Johnson and Johnson Innovative Medicine issued the following news release:
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RYBREVANT FASPRO(TM) (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE(R) (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026
Low rates of rash, blood clots and administration-related reactions were observed with subcutaneous treatment and prophylaxis
Fewer than 1% of patients discontinued treatment due to treatment-related events at one year
New findings from Johnson & Johnson build on the MARIPOSA survival benefit and strengthen ... Show Full Article RARITAN, New Jersey, Sept. 16 -- Johnson and Johnson Innovative Medicine issued the following news release: * * * RYBREVANT FASPRO(TM) (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE(R) (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026 Low rates of rash, blood clots and administration-related reactions were observed with subcutaneous treatment and prophylaxis Fewer than 1% of patients discontinued treatment due to treatment-related events at one year New findings from Johnson & Johnson build on the MARIPOSA survival benefit and strengthenevidence for RYBREVANT FASPRO plus LAZCLUZE as first-line treatment
SEOUL, Sept 14, 2026 - Johnson & Johnson (NYSE:JNJ) today announced new results from the Phase 2b COPERNICUS study evaluating how subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib), with less frequent dosing and prophylactic strategies, can improve the treatment experience for patients with previously untreated advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations. Early results show consistently low rates across key treatment-related events and treatment discontinuation./1
COPERNICUS was designed to reflect everyday clinical practice, enrolling a racially and ethnically diverse patient population across both academic and community sites. The data were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) (Abstract #M012.09)./1
RYBREVANT FASPRO dual-targets EGFR and mesenchymal-epithelial transition (MET), two key drivers of tumor growth and treatment resistance, while also engaging the immune system./2,3,4,5 It is approved across multiple EGFR-mutated advanced NSCLC treatment settings and, for eligible patients, offers once-monthly dosing following initial weekly dosing./6
Advancing the treatment experience with RYBREVANT-based regimens
"RYBREVANT plus LAZCLUZE has already shown that patients with EGFR-mutated lung cancer can live longer, and these latest results mark an important evolution in the treatment approach," said Balazs Halmos, M.D., M.S., Director of Thoracic Oncology and Associate Director of Clinical Science, Montefiore Einstein Comprehensive Cancer Center. "With subcutaneous administration, less frequent dosing and prophylactic strategies, the regimen has been developed with the treatment experience in mind, helping patients start treatment and stay on it."
"Our work with RYBREVANT in EGFR-mutated lung cancer has continued to evolve with each new piece of evidence, from extending survival to advancing how treatment is delivered and managed," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "COPERNICUS brings those learnings together in a study designed around the realities of clinical care. It reflects our commitment to continually innovate across the treatment journey so that scientific advances can make a meaningful difference for more patients."
Detailed study results
In this analysis, 214 U.S. patients received the recently approved RYBREVANT FASPRO plus LAZCLUZE regimen with prophylactic strategies to reduce the risk of blood clots with oral anticoagulation and skin-related side effects with an enhanced, easy-to-use skin care regimen evaluated in the COCOON study./1,7
At a median follow-up of 8.3 months, the majority of adverse events were Grade 1 or 2, with no new safety signals observed. Only eight percent of patients discontinued treatment due to adverse events. Rash was reported in 25 percent of patients, while administration-related reactions (ARRs) and venous thromboembolism (VTE) were each reported in three percent. No patients discontinued due to ARRs, and one percent discontinued due to rash and VTE./1
These findings represent lower numerical rates than observed with intravenous RYBREVANT(R) (amivantamab-vmjw) plus LAZCLUZE in the Phase 3 MARIPOSA study, where rash, ARRs and VTE during the first four months of treatment were reported in 55 percent, 55 percent and 23 percent of patients, respectively. MARIPOSA also demonstrated that patients with advanced EGFR-mutated advanced NSCLC treated with the first-line regimen lived longer than those treated with osimertinib, with a statistically significant overall survival benefit (hazard ratio [HR], 0.75; P=0.005).8
COPERNICUS is one of the largest global studies conducted in patients with EGFR-mutated NSCLC, with a target enrollment of 300 previously untreated patients. Of the population reported here, median age was 67 years, 22 percent were age 75 or older, 27 percent were Asian, 10 percent were African American and 10 percent were Hispanic/Latino./1
This study reflects Johnson & Johnson's continued focus on improving the treatment experience for people with cancer, including how treatments are delivered and managed in everyday care.
About the COPERNICUS study
COPERNICUS (NCT06667076) is a Phase 2b, single-arm study evaluating RYBREVANT FASPRO plus LAZCLUZE with prophylactic strategies in patients with EGFR-mutated advanced non-small cell lung cancer. Cohort 1 evaluates the regimen in the first-line setting, incorporating once-every-four-weeks dosing, venous thromboembolism (VTE) and enhanced dermatologic prophylaxis.
The study uses a pragmatic design to more closely reflect real-world clinical practice, with participation from academic and community sites and reduced visit frequency. The primary endpoint is investigator-assessed progression-free survival per RECIST v1.1. Secondary endpoints include safety and tolerability measures, including VTE and dermatologic adverse events and administration-related reactions, as well as overall survival and overall response rate.9
About non-small cell lung cancer
Worldwide, lung cancer is one of the most common cancers, with non-small cell lung cancer (NSCLC) making up 80 to 85 percent of all lung cancer cases./10,11 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma./12 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division./13 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients./10,11,14,15,16,17 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations./18 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent./19,20 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation./21 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent./22
About RYBREVANT FASPRO and RYBREVANT
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE(R) drug delivery technology.
RYBREVANT FASPRO is approved in the U.S. for the same indications as intravenous RYBREVANT (amivantamab-vmjw) across multiple markets. RYBREVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.
The effectiveness of RYBREVANT FASPRO is supported by the established clinical profile of RYBREVANT, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE(R) in first-line advanced EGFR-mutated NSCLC.
The National Comprehensive Cancer Network(R) (NCCN(R)) Clinical Practice Guidelines in Oncology (NCCN Guidelines(R))/ 23 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT) where appropriate. See the latest NCCN Guidelines(R) for NSCLC for complete information./Sec. ||
The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases./Sec. ||
Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.
The legal manufacturer for RYBREVANT FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.
INDICATIONS
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:
- in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
- in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
- in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
- as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO AND RYBREVANT /6,24
CONTRAINDICATIONS
RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO
RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).
Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.
Infusion-Related Reactions with RYBREVANT
RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.
RYBREVANT with LAZCLUZE
In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.
RYBREVANT as a Single Agent
In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.
Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.
Interstitial Lung Disease/Pneumonitis
RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.
RYBREVANT with LAZCLUZE
In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.
RYBREVANT as a Single Agent
In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.
Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.
Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE
RYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).
RYBREVANT with LAZCLUZE
In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).
Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.
Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.
Dermatologic Adverse Reactions
RYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.
RYBREVANT with LAZCLUZE
In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.
RYBREVANT as a Single Agent
In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).
When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.
If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity
Hepatotoxicity
LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).
RYBREVANT with LAZCLUZE
In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.
Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.
Ocular Toxicity
RYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.
RYBREVANT with LAZCLUZE
In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.
RYBREVANT as a Single Agent
In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.
Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.
Embryo-Fetal Toxicity
Based on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.
ADVERSE REACTIONS
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3 (n=206), the most common adverse reactions (20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).
Serious adverse reactions occurred in 33% of patients, with those occurring in 2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).
RYBREVANT with LAZCLUZE
In MARIPOSA (n=421), the most common adverse reactions (ARs) (20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).
Serious ARs occurred in 49% of patients, with those occurring in 2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).
RYBREVANT with Carboplatin and Pemetrexed
In MARIPOSA-2 (n=130), the most common ARs (20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).
In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).
In PAPILLON (n=151), the most common ARs (20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).
In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in 2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.
RYBREVANT as a Single Agent
In CHRYSALIS (n=129), the most common ARs (20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).
Serious ARs occurred in 30% of patients, with those occurring in 2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.
LAZCLUZE DRUG INTERACTIONS
Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.
Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.
Please see full Prescribing Information for RYBREVANT FASPRO (https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT+Faspro-pi.pdf), RYBREVANT (https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf) and LAZCLUZE (https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/LAZCLUZE-pi.pdf).
cp-491009v2
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About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.
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Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT(R)-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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*/ Balazs Halmos, M.D., M.S., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.
/ RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.
/ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Sec./ See the NCCN Guidelines for detailed recommendations, including other treatment options.
||/ The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.
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Footnotes
1/ Halmos B, et al. Subcutaneous amivantamab + lazertinib with supportive care in EGFR-mutant NSCLC: Longer follow-up from the pragmatic COPERNICUS study. Presented at: IASLC 2026 World Conference on Lung Cancer; 2026; Seoul.
2/ Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833
3/ Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-0071
4/ Yun J, Lee SH, Kim SY, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-0116
5/ Soo R, et al. Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer. Lung Cancer. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6.
6/ RYBREVANT FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
7/ Cho BC, Li W, Spira AI, et al. Enhanced versus standard dermatologic management with amivantamab-lazertinib in EGFR-mutated advanced NSCLC: the COCOON global randomized controlled trial. J Thorac Oncol. 2025;20(10):1517-1530. doi:10.1016/j.jtho.2025.07.117.
8/ Yang JCH, Lu S, Hayashi H, et al. Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC. N Engl J Med. 2025;393(17):1681-1693. doi:10.1056/NEJMoa2503001.
9/ ClinicalTrials.gov. A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS). Accessed September 2026. https://clinicaltrials.gov/study/NCT06667076
10/ The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed September 2026.
11/ American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed September 2026.
12/ Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.
13/ Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
14/ Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 2019;37(2):97-104.
15/ Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
16/ Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.
17/ Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.
18/ American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed September 2026.
19/ Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site.
20/ Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.
21/ Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9.
22/ Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
23/ Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines(R)) for Non-Small Cell Lung Cancer V.7.2026 Copyright (c) National Comprehensive Cancer Network, Inc. All rights reserved. Accessed September 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.
24/ RYBREVANT [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
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Original text here: https://www.jnj.com/media-center/press-releases/rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-plus-lazcluze-lazertinib-with-prophylactic-strategies-shows-low-rates-of-treatment-related-events-at-wclc-2026
[Category: BizPharmaceuticals]
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RYBREVANT FASPRO(TM) (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE(R) (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026
Low rates of rash, blood clots and administration-related reactions were observed with subcutaneous treatment and prophylaxis
Fewer than 1% of patients discontinued treatment due to treatment-related events at one year
New findings from Johnson & Johnson build on the MARIPOSA survival benefit and strengthen ... Show Full Article RARITAN, New Jersey, Sept. 16 -- Johnson and Johnson Innovative Medicine issued the following news release: * * * RYBREVANT FASPRO(TM) (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE(R) (lazertinib) with prophylactic strategies shows low rates of treatment-related events at WCLC 2026 Low rates of rash, blood clots and administration-related reactions were observed with subcutaneous treatment and prophylaxis Fewer than 1% of patients discontinued treatment due to treatment-related events at one year New findings from Johnson & Johnson build on the MARIPOSA survival benefit and strengthenevidence for RYBREVANT FASPRO plus LAZCLUZE as first-line treatment
SEOUL, Sept 14, 2026 - Johnson & Johnson (NYSE:JNJ) today announced new results from the Phase 2b COPERNICUS study evaluating how subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) plus LAZCLUZE (lazertinib), with less frequent dosing and prophylactic strategies, can improve the treatment experience for patients with previously untreated advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations. Early results show consistently low rates across key treatment-related events and treatment discontinuation./1
COPERNICUS was designed to reflect everyday clinical practice, enrolling a racially and ethnically diverse patient population across both academic and community sites. The data were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) (Abstract #M012.09)./1
RYBREVANT FASPRO dual-targets EGFR and mesenchymal-epithelial transition (MET), two key drivers of tumor growth and treatment resistance, while also engaging the immune system./2,3,4,5 It is approved across multiple EGFR-mutated advanced NSCLC treatment settings and, for eligible patients, offers once-monthly dosing following initial weekly dosing./6
Advancing the treatment experience with RYBREVANT-based regimens
"RYBREVANT plus LAZCLUZE has already shown that patients with EGFR-mutated lung cancer can live longer, and these latest results mark an important evolution in the treatment approach," said Balazs Halmos, M.D., M.S., Director of Thoracic Oncology and Associate Director of Clinical Science, Montefiore Einstein Comprehensive Cancer Center. "With subcutaneous administration, less frequent dosing and prophylactic strategies, the regimen has been developed with the treatment experience in mind, helping patients start treatment and stay on it."
"Our work with RYBREVANT in EGFR-mutated lung cancer has continued to evolve with each new piece of evidence, from extending survival to advancing how treatment is delivered and managed," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "COPERNICUS brings those learnings together in a study designed around the realities of clinical care. It reflects our commitment to continually innovate across the treatment journey so that scientific advances can make a meaningful difference for more patients."
Detailed study results
In this analysis, 214 U.S. patients received the recently approved RYBREVANT FASPRO plus LAZCLUZE regimen with prophylactic strategies to reduce the risk of blood clots with oral anticoagulation and skin-related side effects with an enhanced, easy-to-use skin care regimen evaluated in the COCOON study./1,7
At a median follow-up of 8.3 months, the majority of adverse events were Grade 1 or 2, with no new safety signals observed. Only eight percent of patients discontinued treatment due to adverse events. Rash was reported in 25 percent of patients, while administration-related reactions (ARRs) and venous thromboembolism (VTE) were each reported in three percent. No patients discontinued due to ARRs, and one percent discontinued due to rash and VTE./1
These findings represent lower numerical rates than observed with intravenous RYBREVANT(R) (amivantamab-vmjw) plus LAZCLUZE in the Phase 3 MARIPOSA study, where rash, ARRs and VTE during the first four months of treatment were reported in 55 percent, 55 percent and 23 percent of patients, respectively. MARIPOSA also demonstrated that patients with advanced EGFR-mutated advanced NSCLC treated with the first-line regimen lived longer than those treated with osimertinib, with a statistically significant overall survival benefit (hazard ratio [HR], 0.75; P=0.005).8
COPERNICUS is one of the largest global studies conducted in patients with EGFR-mutated NSCLC, with a target enrollment of 300 previously untreated patients. Of the population reported here, median age was 67 years, 22 percent were age 75 or older, 27 percent were Asian, 10 percent were African American and 10 percent were Hispanic/Latino./1
This study reflects Johnson & Johnson's continued focus on improving the treatment experience for people with cancer, including how treatments are delivered and managed in everyday care.
About the COPERNICUS study
COPERNICUS (NCT06667076) is a Phase 2b, single-arm study evaluating RYBREVANT FASPRO plus LAZCLUZE with prophylactic strategies in patients with EGFR-mutated advanced non-small cell lung cancer. Cohort 1 evaluates the regimen in the first-line setting, incorporating once-every-four-weeks dosing, venous thromboembolism (VTE) and enhanced dermatologic prophylaxis.
The study uses a pragmatic design to more closely reflect real-world clinical practice, with participation from academic and community sites and reduced visit frequency. The primary endpoint is investigator-assessed progression-free survival per RECIST v1.1. Secondary endpoints include safety and tolerability measures, including VTE and dermatologic adverse events and administration-related reactions, as well as overall survival and overall response rate.9
About non-small cell lung cancer
Worldwide, lung cancer is one of the most common cancers, with non-small cell lung cancer (NSCLC) making up 80 to 85 percent of all lung cancer cases./10,11 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma./12 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division./13 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients./10,11,14,15,16,17 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations./18 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent./19,20 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation./21 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent./22
About RYBREVANT FASPRO and RYBREVANT
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved for these EGFR-mutated NSCLC populations and may be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy, depending on the specific mutation and treatment setting. For eligible patients, RYBREVANT FASPRO offers a once-monthly dosing option following initial weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE(R) drug delivery technology.
RYBREVANT FASPRO is approved in the U.S. for the same indications as intravenous RYBREVANT (amivantamab-vmjw) across multiple markets. RYBREVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.
The effectiveness of RYBREVANT FASPRO is supported by the established clinical profile of RYBREVANT, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE(R) in first-line advanced EGFR-mutated NSCLC.
The National Comprehensive Cancer Network(R) (NCCN(R)) Clinical Practice Guidelines in Oncology (NCCN Guidelines(R))/ 23 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT) where appropriate. See the latest NCCN Guidelines(R) for NSCLC for complete information./Sec. ||
The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases./Sec. ||
Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.
The legal manufacturer for RYBREVANT FASPRO and RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.
INDICATIONS
RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) and RYBREVANT (amivantamab-vmjw) are indicated:
- in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
- in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
- in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
- as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO AND RYBREVANT /6,24
CONTRAINDICATIONS
RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO
RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).
Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.
Infusion-Related Reactions with RYBREVANT
RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.
RYBREVANT with LAZCLUZE
In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.
RYBREVANT as a Single Agent
In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.
Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.
Interstitial Lung Disease/Pneumonitis
RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.
RYBREVANT with LAZCLUZE
In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.
RYBREVANT as a Single Agent
In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.
Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.
Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE
RYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).
RYBREVANT with LAZCLUZE
In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).
Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.
Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.
Dermatologic Adverse Reactions
RYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.
RYBREVANT with LAZCLUZE
In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.
RYBREVANT as a Single Agent
In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).
When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.
If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity
Hepatotoxicity
LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).
RYBREVANT with LAZCLUZE
In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.
Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.
Ocular Toxicity
RYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.
RYBREVANT with LAZCLUZE
In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.
RYBREVANT with Carboplatin and Pemetrexed
Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.
RYBREVANT as a Single Agent
In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.
Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.
Embryo-Fetal Toxicity
Based on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.
ADVERSE REACTIONS
RYBREVANT FASPRO with LAZCLUZE
In PALOMA-3 (n=206), the most common adverse reactions (20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gamma-glutamyl transferase (2%), and decreased hemoglobin (2%).
Serious adverse reactions occurred in 33% of patients, with those occurring in 2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).
RYBREVANT with LAZCLUZE
In MARIPOSA (n=421), the most common adverse reactions (ARs) (20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).
Serious ARs occurred in 49% of patients, with those occurring in 2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).
RYBREVANT with Carboplatin and Pemetrexed
In MARIPOSA-2 (n=130), the most common ARs (20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).
In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).
In PAPILLON (n=151), the most common ARs (20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).
In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in 2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.
RYBREVANT as a Single Agent
In CHRYSALIS (n=129), the most common ARs (20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).
Serious ARs occurred in 30% of patients, with those occurring in 2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.
LAZCLUZE DRUG INTERACTIONS
Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.
Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.
Please see full Prescribing Information for RYBREVANT FASPRO (https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT+Faspro-pi.pdf), RYBREVANT (https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf) and LAZCLUZE (https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/LAZCLUZE-pi.pdf).
cp-491009v2
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About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.
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Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of RYBREVANT(R)-based regimens. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
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*/ Balazs Halmos, M.D., M.S., has served as a consultant to Johnson & Johnson; he has not been paid for any media work.
/ RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumors, which is a standard way to measure how well solid tumors respond to treatment and is based on whether tumors shrink, stay the same or get bigger.
/ The NCCN content does not constitute medical advice and should not be used in place of seeking professional medical advice, diagnosis or treatment by licensed practitioners. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Sec./ See the NCCN Guidelines for detailed recommendations, including other treatment options.
||/ The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.
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Footnotes
1/ Halmos B, et al. Subcutaneous amivantamab + lazertinib with supportive care in EGFR-mutant NSCLC: Longer follow-up from the pragmatic COPERNICUS study. Presented at: IASLC 2026 World Conference on Lung Cancer; 2026; Seoul.
2/ Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res. 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833
3/ Vijayaraghavan S, Lipfert L, Chevalier K, et al. Amivantamab (JNJ-61186372), an Fc Enhanced EGFR/cMet Bispecific Antibody, Induces Receptor Downmodulation and Antitumor Activity by Monocyte/Macrophage Trogocytosis. Mol Cancer Ther. 2020;19(10):2044-2056. doi:10.1158/1535-7163.MCT-20-0071
4/ Yun J, Lee SH, Kim SY, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC. Cancer Discov. 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-0116
5/ Soo R, et al. Asia-Pacific practical consensus in the management of adverse events related to amivantamab-based therapies in non-small cell lung cancer. Lung Cancer. Published online May 22, 2026. doi:10.1016/S0169-5002(26)00466-6.
6/ RYBREVANT FASPRO [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
7/ Cho BC, Li W, Spira AI, et al. Enhanced versus standard dermatologic management with amivantamab-lazertinib in EGFR-mutated advanced NSCLC: the COCOON global randomized controlled trial. J Thorac Oncol. 2025;20(10):1517-1530. doi:10.1016/j.jtho.2025.07.117.
8/ Yang JCH, Lu S, Hayashi H, et al. Overall survival with amivantamab-lazertinib in EGFR-mutated advanced NSCLC. N Engl J Med. 2025;393(17):1681-1693. doi:10.1056/NEJMoa2503001.
9/ ClinicalTrials.gov. A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS). Accessed September 2026. https://clinicaltrials.gov/study/NCT06667076
10/ The World Health Organization. Cancer. https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed September 2026.
11/ American Cancer Society. What is Lung Cancer? https://www.cancer.org/content/cancer/en/cancer/lung-cancer/about/what-is.html. Accessed September 2026.
12/ Oxnard JR, et al. Natural history and molecular characteristics of lung cancers harboring EGFR exon 20 insertions. J Thorac Oncol. 2013 Feb;8(2):179-84. doi: 10.1097/JTO.0b013e3182779d18.
13/ Bauml JM, et al. Underdiagnosis of EGFR Exon 20 Insertion Mutation Variants: Estimates from NGS-based Real World Datasets. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
14/ Pennell NA, et al. A phase II trial of adjuvant erlotinib in patients with resected epidermal growth factor receptor-mutant non-small cell lung cancer. J Clin Oncol. 2019;37(2):97-104.
15/ Burnett H, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
16/ Zhang YL, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7(48):78985-78993.
17/ Midha A, et al. EGFR mutation incidence in non-small-cell lung cancer of adenocarcinoma histology: a systematic review and global map by ethnicity. Am J Cancer Res. 2015;5(9):2892-2911.
18/ American Lung Association. EGFR and Lung Cancer. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/egfr. Accessed September 2026.
19/ Howlader N, et al. SEER Cancer Statistics Review, 1975-2016, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2016/, based on November 2018 SEER data submission, posted to the SEER web site.
20/ Lin JJ, et al. Five-Year Survival in EGFR-Mutant Metastatic Lung Adenocarcinoma Treated with EGFR-TKIs. J Thorac Oncol. 2016 Apr;11(4):556-65.
21/ Arcila, M. et al. EGFR exon 20 insertion mutations in lung adenocarcinomas: prevalence, molecular heterogeneity, and clinicopathologic characteristics. Mol Cancer Ther. 2013 Feb; 12(2):220-9.
22/ Girard N, et al. Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Abstract presented at: World Conference on Lung Cancer Annual Meeting; January 29, 2021; Singapore.
23/ Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines(R)) for Non-Small Cell Lung Cancer V.7.2026 Copyright (c) National Comprehensive Cancer Network, Inc. All rights reserved. Accessed September 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.
24/ RYBREVANT [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
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Original text here: https://www.jnj.com/media-center/press-releases/rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-plus-lazcluze-lazertinib-with-prophylactic-strategies-shows-low-rates-of-treatment-related-events-at-wclc-2026
[Category: BizPharmaceuticals]
DuPont Launches Tyvek With Renewable Attribution for Consumer & Industrial Applications
WILMINGTON, Delaware, Sept. 16 -- DuPont issued the following news release:
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DuPont Launches Tyvek(R) with Renewable Attribution for Consumer & Industrial Applications
Enabling customers to achieve more sustainable material sourcing without changing how they use Tyvek(R)
WILMINGTON, Del., Sept. 15, 2026 - DuPont (NYSE: DD) today announced the global launch of Tyvek(R) with Renewable Attribution for Consumer & Industrial (C&I) applications, extending its certified bio-circular material innovation to customers in active packaging, tags and labels, race bibs and wristbands, as well as industrial ... Show Full Article WILMINGTON, Delaware, Sept. 16 -- DuPont issued the following news release: * * * DuPont Launches Tyvek(R) with Renewable Attribution for Consumer & Industrial Applications Enabling customers to achieve more sustainable material sourcing without changing how they use Tyvek(R) WILMINGTON, Del., Sept. 15, 2026 - DuPont (NYSE: DD) today announced the global launch of Tyvek(R) with Renewable Attribution for Consumer & Industrial (C&I) applications, extending its certified bio-circular material innovation to customers in active packaging, tags and labels, race bibs and wristbands, as well as industrialpackaging such as art packaging, dunnage and industrial bags.
As companies work to reduce its carbon footprint, including through Scope 3 emissions reduction, Tyvek(R) with Renewable Attribution offers a practical route to lower-carbon material sourcing. Most importantly, customers can transition to this innovative technology without redesigning their products or processes.
"Tyvek(R) with Renewable Attribution provides customers with a credible solution that maintains the performance they know while supporting progress on sustainable material sourcing and carbon footprint reduction. It is one step in the journey as we work towards implementing our sustainability strategy, and we will continue to go further as we work to reduce the environmental footprint of Tyvek(R) manufacturing and collaborate across the value chain to advance circularity of the product," said Jonathan Brunette, Sustainability Application Development Engineer, DuPont(TM) Tyvek(R) C&I.
Tyvek(R) with Renewable Attribution is available at renewable attribution levels from 30% to 100%, linked to ISCC PLUS-certified bio-circular material on a mass balance basis. Under this approach, certified bio-circular feedstocks are introduced and tracked within the upstream supply chain supporting a reduction in reliance on fossil feedstocks. The renewable feedstocks are then attributed to the purchased HDPE. The bio-circular feedstocks are derived from second-generation biomass, including waste and residues that do not compete with food production - resulting in more responsible material sourcing without placing additional pressure on agricultural resources or food supply chains.
Through the ISCC PLUS-certified mass balance approach, an equivalent amount of certified bio-circular feedstock is allocated to Tyvek(R) with Renewable Attribution. This enables customers to select a renewable attribution level from 30% to 100%[1], with the carbon footprint reduction linked to the level chosen. At a 30% renewable attribution level, Tyvek(R) with Renewable Attribution supports an approximately 30% reduction in carbon footprint (including CO2 uptake) compared to standard Tyvek(R), based on peer-reviewed, ISO-compliant life cycle assessment data.
Because Tyvek(R) with Renewable Attribution is produced to the same product specifications as conventional Tyvek(R), customers can continue to rely on the same proven performance characteristics across their existing applications. This means they can take a measurable step toward more sustainable material sourcing and a reduced product carbon footprint without compromising durability, reliability or usability. Importantly, the product is a drop in solution, with no requalification needed, helping make adoption simpler and faster for existing Tyvek(R) users.
DuPont(TM) Tyvek(R) is an ISCC PLUS certificate holder at its Luxembourg and Richmond, Virginia manufacturing sites. As part of the voluntary ISCC PLUS certification process, which validates sustainability characteristics of alternative feedstocks across the value chain, the sites receive annual third-party audits and support transparent measurement, tracking and attribution of certified bio-circular feedstocks using the mass balance approach. This helps support traceability, feedstock identity, transparency and accurate renewable attribution. The launch also aligns with DuPont's wider sustainability strategy, including its 2035 Sustainability Goals and focus on enabling circularity, reducing environmental impact and supporting customers with innovative solutions that deliver direct sustainability advantages.
For more information on Tyvek(R) with Renewable Attribution, please visit https://www.dupont.com/consumer-and-industrial-applications/tyvek-with-renewable-attribution.html.
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[1] For active packaging, Tyvek(R) with Renewable Attribution is currently available up to 30% Renewable Attribution on HealthCare styles.
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About DuPont(TM) Tyvek(R) Consumer & Industrial
DuPont(TM) Tyvek(R) is a high-performance material that serves a wide range of consumer and industrial applications. Lightweight, durable, breathable, water-resistant and highly printable, Tyvek(R) combines reliable performance with creative flexibility.
Tyvek(R) is widely used in packaging, graphics, and consumer applications - including industrial and active packaging, wristbands, tags & labels, and consumer products, helping brands and manufacturers create solutions that stand out while delivering reliable protection and durability.
Driven by science-based innovation and global expertise, Tyvek(R) works closely with Consumer & Industrial partners to bring ideas to life with confidence and consistency.
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About DuPont
DuPont (NYSE: DD) is a global innovation leader, providing advanced solutions that help transform industries and improve everyday life across our key markets of healthcare, water, construction, and industrial. More information about the company, its businesses and solutions can be found at www.dupont.com. Investors can access information included on the Investor Relations section of the website at investors.dupont.com.
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Original text here: https://www.dupont.com/news/dupont-launches-tyvek-with-renewable-attribution-for-customer-and-industrial-applications.html
[Category: BizLaboratory Sciences]
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DuPont Launches Tyvek(R) with Renewable Attribution for Consumer & Industrial Applications
Enabling customers to achieve more sustainable material sourcing without changing how they use Tyvek(R)
WILMINGTON, Del., Sept. 15, 2026 - DuPont (NYSE: DD) today announced the global launch of Tyvek(R) with Renewable Attribution for Consumer & Industrial (C&I) applications, extending its certified bio-circular material innovation to customers in active packaging, tags and labels, race bibs and wristbands, as well as industrial ... Show Full Article WILMINGTON, Delaware, Sept. 16 -- DuPont issued the following news release: * * * DuPont Launches Tyvek(R) with Renewable Attribution for Consumer & Industrial Applications Enabling customers to achieve more sustainable material sourcing without changing how they use Tyvek(R) WILMINGTON, Del., Sept. 15, 2026 - DuPont (NYSE: DD) today announced the global launch of Tyvek(R) with Renewable Attribution for Consumer & Industrial (C&I) applications, extending its certified bio-circular material innovation to customers in active packaging, tags and labels, race bibs and wristbands, as well as industrialpackaging such as art packaging, dunnage and industrial bags.
As companies work to reduce its carbon footprint, including through Scope 3 emissions reduction, Tyvek(R) with Renewable Attribution offers a practical route to lower-carbon material sourcing. Most importantly, customers can transition to this innovative technology without redesigning their products or processes.
"Tyvek(R) with Renewable Attribution provides customers with a credible solution that maintains the performance they know while supporting progress on sustainable material sourcing and carbon footprint reduction. It is one step in the journey as we work towards implementing our sustainability strategy, and we will continue to go further as we work to reduce the environmental footprint of Tyvek(R) manufacturing and collaborate across the value chain to advance circularity of the product," said Jonathan Brunette, Sustainability Application Development Engineer, DuPont(TM) Tyvek(R) C&I.
Tyvek(R) with Renewable Attribution is available at renewable attribution levels from 30% to 100%, linked to ISCC PLUS-certified bio-circular material on a mass balance basis. Under this approach, certified bio-circular feedstocks are introduced and tracked within the upstream supply chain supporting a reduction in reliance on fossil feedstocks. The renewable feedstocks are then attributed to the purchased HDPE. The bio-circular feedstocks are derived from second-generation biomass, including waste and residues that do not compete with food production - resulting in more responsible material sourcing without placing additional pressure on agricultural resources or food supply chains.
Through the ISCC PLUS-certified mass balance approach, an equivalent amount of certified bio-circular feedstock is allocated to Tyvek(R) with Renewable Attribution. This enables customers to select a renewable attribution level from 30% to 100%[1], with the carbon footprint reduction linked to the level chosen. At a 30% renewable attribution level, Tyvek(R) with Renewable Attribution supports an approximately 30% reduction in carbon footprint (including CO2 uptake) compared to standard Tyvek(R), based on peer-reviewed, ISO-compliant life cycle assessment data.
Because Tyvek(R) with Renewable Attribution is produced to the same product specifications as conventional Tyvek(R), customers can continue to rely on the same proven performance characteristics across their existing applications. This means they can take a measurable step toward more sustainable material sourcing and a reduced product carbon footprint without compromising durability, reliability or usability. Importantly, the product is a drop in solution, with no requalification needed, helping make adoption simpler and faster for existing Tyvek(R) users.
DuPont(TM) Tyvek(R) is an ISCC PLUS certificate holder at its Luxembourg and Richmond, Virginia manufacturing sites. As part of the voluntary ISCC PLUS certification process, which validates sustainability characteristics of alternative feedstocks across the value chain, the sites receive annual third-party audits and support transparent measurement, tracking and attribution of certified bio-circular feedstocks using the mass balance approach. This helps support traceability, feedstock identity, transparency and accurate renewable attribution. The launch also aligns with DuPont's wider sustainability strategy, including its 2035 Sustainability Goals and focus on enabling circularity, reducing environmental impact and supporting customers with innovative solutions that deliver direct sustainability advantages.
For more information on Tyvek(R) with Renewable Attribution, please visit https://www.dupont.com/consumer-and-industrial-applications/tyvek-with-renewable-attribution.html.
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[1] For active packaging, Tyvek(R) with Renewable Attribution is currently available up to 30% Renewable Attribution on HealthCare styles.
* * *
About DuPont(TM) Tyvek(R) Consumer & Industrial
DuPont(TM) Tyvek(R) is a high-performance material that serves a wide range of consumer and industrial applications. Lightweight, durable, breathable, water-resistant and highly printable, Tyvek(R) combines reliable performance with creative flexibility.
Tyvek(R) is widely used in packaging, graphics, and consumer applications - including industrial and active packaging, wristbands, tags & labels, and consumer products, helping brands and manufacturers create solutions that stand out while delivering reliable protection and durability.
Driven by science-based innovation and global expertise, Tyvek(R) works closely with Consumer & Industrial partners to bring ideas to life with confidence and consistency.
* * *
About DuPont
DuPont (NYSE: DD) is a global innovation leader, providing advanced solutions that help transform industries and improve everyday life across our key markets of healthcare, water, construction, and industrial. More information about the company, its businesses and solutions can be found at www.dupont.com. Investors can access information included on the Investor Relations section of the website at investors.dupont.com.
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Original text here: https://www.dupont.com/news/dupont-launches-tyvek-with-renewable-attribution-for-customer-and-industrial-applications.html
[Category: BizLaboratory Sciences]
Citi Chair and CEO Jane Fraser Meets With Senior Leadership of the United Arab Emirates to Reaffirm Citi's Commitment to the Region
NEW YORK, Sept. 16 -- Citi, a banking partner for institutions with cross-border needs and wealth management and a personal bank, issued the following news release:
* * *
Citi Chair and CEO Jane Fraser Meets with Senior Leadership of the United Arab Emirates to Reaffirm Citi's Commitment to the Region
September 15, 2026
HIGHLIGHTS
* Citi Chair and CEO Jane Fraser met with senior leadership of the United Arab Emirates, including His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, to reaffirm the firm's deep commitment to the country
* Discussions centered on the UAE's diversifying ... Show Full Article NEW YORK, Sept. 16 -- Citi, a banking partner for institutions with cross-border needs and wealth management and a personal bank, issued the following news release: * * * Citi Chair and CEO Jane Fraser Meets with Senior Leadership of the United Arab Emirates to Reaffirm Citi's Commitment to the Region September 15, 2026 HIGHLIGHTS * Citi Chair and CEO Jane Fraser met with senior leadership of the United Arab Emirates, including His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, to reaffirm the firm's deep commitment to the country * Discussions centered on the UAE's diversifyingeconomy, long-term growth agenda and opportunities for its public and private sectors to expand into new markets
* With a 60-year history in the country, Citi continues to support clients across the Middle East, raising more than $75 billion in the first eight months of 2026
ABU DHABI - Citi Chair and CEO Jane Fraser this week met with senior leadership of the United Arab Emirates, including His Highness, Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, The Crown Prince of Abu Dhabi. The two leaders discussed Citi's conviction in and commitment to the country and the depth of support the firm provides to clients across the UAE and the Gulf region.
The themes covered the global macroeconomic outlook for the region, the significant business opportunities emerging across the UAE's diversifying economy, and the development of AI, among other priorities central to the country's long-term growth agenda. They also examined opportunities for the UAE's public and private sector institutions to expand their reach into new markets around the world with Citi's support.
"It's always an honor and a privilege to meet with the leadership of the UAE and hear firsthand their vision for the UAE's future," said Fraser. "Few countries have matched the UAE's extraordinary ambition or its record of delivering on it. Its visionary leaders have built one of the world's most dynamic and resilient economies, and a nation whose mindset is to build what it needs for the future. At the heart of that ambition is investment in technology and sustainable infrastructure, positioning the UAE to lead the next era of global growth. Our confidence in its direction has never been stronger in our 60 years in the country, and Citi is deeply committed to bringing the full power of our global network to its continued success."
Beyond high-level government engagements, Fraser's visit centered on deepening Citi's partnerships across the region. While in the UAE, she held discussions on cross-border growth strategies and clients' access to the bank's global network. She also spent time with Citi's nearly 2,000 colleagues in the region, recognizing the team's vital role in driving the bank's Middle East and Africa strategy.
Citi has operated in the UAE since 1964, when it opened its first branch in Dubai as the first American bank in the country, later expanding to Abu Dhabi. In the first eight months of 2026, Citi raised more than $75 billion to support clients across the Middle East. The firm was named Best Investment Bank for M&A for the UAE and Middle East in 2025 by Euromoney.
* * *
About Citi
Citi is a preeminent banking partner for institutions with cross-border needs, a global leader in wealth management and a valued personal bank in its home market of the United States. Citi does business in more than 180 countries and jurisdictions, providing corporations, governments, investors, institutions and individuals with a broad range of financial products and services.
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Original text here: https://www.citigroup.com/global/news/press-release/2026/chair-and-ceo-jane-fraser-meets-with-senior-leadership-of-the-united-arab-emirates-to-reaffirm-citis-commitment-to-the-region
[Category: BizFinancial Services]
* * *
Citi Chair and CEO Jane Fraser Meets with Senior Leadership of the United Arab Emirates to Reaffirm Citi's Commitment to the Region
September 15, 2026
HIGHLIGHTS
* Citi Chair and CEO Jane Fraser met with senior leadership of the United Arab Emirates, including His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, to reaffirm the firm's deep commitment to the country
* Discussions centered on the UAE's diversifying ... Show Full Article NEW YORK, Sept. 16 -- Citi, a banking partner for institutions with cross-border needs and wealth management and a personal bank, issued the following news release: * * * Citi Chair and CEO Jane Fraser Meets with Senior Leadership of the United Arab Emirates to Reaffirm Citi's Commitment to the Region September 15, 2026 HIGHLIGHTS * Citi Chair and CEO Jane Fraser met with senior leadership of the United Arab Emirates, including His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, to reaffirm the firm's deep commitment to the country * Discussions centered on the UAE's diversifyingeconomy, long-term growth agenda and opportunities for its public and private sectors to expand into new markets
* With a 60-year history in the country, Citi continues to support clients across the Middle East, raising more than $75 billion in the first eight months of 2026
ABU DHABI - Citi Chair and CEO Jane Fraser this week met with senior leadership of the United Arab Emirates, including His Highness, Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, The Crown Prince of Abu Dhabi. The two leaders discussed Citi's conviction in and commitment to the country and the depth of support the firm provides to clients across the UAE and the Gulf region.
The themes covered the global macroeconomic outlook for the region, the significant business opportunities emerging across the UAE's diversifying economy, and the development of AI, among other priorities central to the country's long-term growth agenda. They also examined opportunities for the UAE's public and private sector institutions to expand their reach into new markets around the world with Citi's support.
"It's always an honor and a privilege to meet with the leadership of the UAE and hear firsthand their vision for the UAE's future," said Fraser. "Few countries have matched the UAE's extraordinary ambition or its record of delivering on it. Its visionary leaders have built one of the world's most dynamic and resilient economies, and a nation whose mindset is to build what it needs for the future. At the heart of that ambition is investment in technology and sustainable infrastructure, positioning the UAE to lead the next era of global growth. Our confidence in its direction has never been stronger in our 60 years in the country, and Citi is deeply committed to bringing the full power of our global network to its continued success."
Beyond high-level government engagements, Fraser's visit centered on deepening Citi's partnerships across the region. While in the UAE, she held discussions on cross-border growth strategies and clients' access to the bank's global network. She also spent time with Citi's nearly 2,000 colleagues in the region, recognizing the team's vital role in driving the bank's Middle East and Africa strategy.
Citi has operated in the UAE since 1964, when it opened its first branch in Dubai as the first American bank in the country, later expanding to Abu Dhabi. In the first eight months of 2026, Citi raised more than $75 billion to support clients across the Middle East. The firm was named Best Investment Bank for M&A for the UAE and Middle East in 2025 by Euromoney.
* * *
About Citi
Citi is a preeminent banking partner for institutions with cross-border needs, a global leader in wealth management and a valued personal bank in its home market of the United States. Citi does business in more than 180 countries and jurisdictions, providing corporations, governments, investors, institutions and individuals with a broad range of financial products and services.
* * *
Original text here: https://www.citigroup.com/global/news/press-release/2026/chair-and-ceo-jane-fraser-meets-with-senior-leadership-of-the-united-arab-emirates-to-reaffirm-citis-commitment-to-the-region
[Category: BizFinancial Services]
CESAR Brand and Lacey Chabert Declare: We Should Totally "Just Eat CESAR!" With Limited-edition Pink Pack
MCLEAN, Virginia, Sept. 16 -- CESAR, a part of Mars Inc., issued the following news release:
* * *
The CESAR(R) brand and Lacey Chabert declare: We should totally "Just Eat CESAR!" with limited-edition Pink Pack
Ahead of the October 3rd pop-culture tradition that has fans seeing pink, the CESAR brand and Lacey Chabert are finally making fetch happen with a nutritious glow-up for dogs' everyday mealtime
Here's the hot gossip:
- What is the "Just Eat CESAR!" Campaign? The "Just Eat CESAR!" campaign is a playful partnership between the CESAR(R) brand and Lacey Chabert, giving dogs a starring ... Show Full Article MCLEAN, Virginia, Sept. 16 -- CESAR, a part of Mars Inc., issued the following news release: * * * The CESAR(R) brand and Lacey Chabert declare: We should totally "Just Eat CESAR!" with limited-edition Pink Pack Ahead of the October 3rd pop-culture tradition that has fans seeing pink, the CESAR brand and Lacey Chabert are finally making fetch happen with a nutritious glow-up for dogs' everyday mealtime Here's the hot gossip: - What is the "Just Eat CESAR!" Campaign? The "Just Eat CESAR!" campaign is a playful partnership between the CESAR(R) brand and Lacey Chabert, giving dogs a starringrole in the pop culture celebration of October 3. Through exclusive videos and social content, Lacey brings the campaign to life, alongside the launch of the exclusive, limited-edition CESAR Pink Pack, featuring varieties that showcase the color pink in their packaging. The 12-pack features three complete and balanced recipes: Classic Loaf in Sauce Porterhouse Steak Flavor, Filets in Gravy Prime Rib Flavor and Classic Loaf in Sauce Smoked Bacon & Egg Flavor, offering wholesome, nutritious CESAR wet food for everyday mealtime.
- When and where can pet parents get the CESAR Pink Pack? The limited-edition CESAR Pink Pack will be available for free on a first-come, first-served basis exclusively on Wednesday, September 16 and Wednesday, September 23 at CESAR.com/JustEatCesar while supplies last./*
- How can fans celebrate from anywhere? From September 16-23, 2026, fans are encouraged to celebrate in their own way by taking part in one or more of the following: sharing their own pink-inspired CESAR moments with their dog on Instagram and TikTok using #CESARShare, engaging with exclusive social content from Lacey Chabert, claiming the Pink Pack at CESAR.com/JustEatCesar, or earning rewards through Go Fetch Rewards on the Fetch App.
FRANKLIN, Tenn. (Sept. 15, 2026) - Every fall, one of the internet's most beloved pop culture traditions takes over social media as fans celebrate October 3 with iconic quotes, pink fashion and nostalgic throwbacks. This year, the CESAR(R) brand is joining forces with actress, mom and dog lover Lacey Chabert to give dogs their own starring role in the fun.
Known for her iconic role as an unapologetic, pink-clad trendsetter famous for spilling secrets, Lacey and the CESAR brand are putting a fresh, furry spin on one of cinema's most legendary rants, declaring: We should totally "Just Eat CESAR!" The playful, social-first campaign celebrates dogs, mealtime and the everyday bond they share with the people who love them, headlined by the launch of the limited-edition CESAR Pink Pack, created for pet parents who embody the spirit of Love Like Crazy(TM).
"While Wednesdays will always belong to the color pink, CESAR cuisine provides wholesome, nutritious meals dogs deserve every day," said Lacey Chabert. "We shouldn't save the good stuff for a rare treat! As a dog lover, I'm thrilled to help the CESAR brand show pet parents that giving their dogs high-quality food is the best daily routine."
The CESAR brand and Lacey Chabert bring the campaign to life this fall with exclusive drops of the CESAR Pink Pack on Wednesday, September 16 and Wednesday, September 23 at CESAR.com/JustEatCesar, because on Wednesdays (and every day), dogs should Just Eat CESAR!/*
The limited-edition CESAR Pink Pack invites pet parents and their dogs to become cafeteria royalty with a 12-pack bundle featuring tongue-out tasty CESAR wet food recipes, including:
- Classic Loaf in Sauce Porterhouse Steak Flavor
- Filets in Gravy Prime Rib Flavor
- Classic Loaf in Sauce Smoked Bacon & Egg Flavor
Crafted with high-quality, purposeful ingredients, each recipe delivers a 100% complete and balanced nutrition, making the CESAR brand a wholesome, delicious meal dogs deserve every day.
"We're thrilled to unveil the re-energized visual identity for our brand - a fresh glow-up of our logo, beloved Westie dog, and new signature color: pink," said Lina Tinsley, Brand Director for CESAR U.S. "With this new campaign, we're bringing that pink identity to life, giving pet parents a fun new way to celebrate a pop culture moment and show their dogs extra love. Because at its heart, CESAR is all about flavorful variety, quality nutrition, and delightful shared experiences."
The celebration doesn't stop with the Pink Pack.
Lacey Chabert will bring the drama (the good kind!) to social media through a series of exclusive social videos, giving fans a front-row seat to see what makes the CESAR brand the queen bee of pet food with its slow-cooked and perfectly balanced recipes.
Fans are encouraged to claim the exclusive drop and share their own, pink-inspired moments with their dog -- whether it's a CESAR Pink Pack, a pink pup accessory, or their dog's best "posse" post. Fans can tag @cesardogfood_us on Instagram and @cesardogfood on TikTok using #CESARShare to officially join the "Just Eat CESAR!" squad.
Every CESAR Pink Pack also includes an insert card linking directly to Go Fetch Rewards on the Fetch App, where pet parents can earn points and unlock rewards for their pups./*
* * *
About Mars, Incorporated
Mars, Incorporated is driven by the belief that the world we want tomorrow starts with how we do business today. Based on combined Mars and Kellanova 2025 net sales, we are a $65bn+ family-owned business with 170,000 Associates, our diverse portfolio of leading pet care products and veterinary services serve pets all around the world and our quality snacking and food products delights millions of people every day. We produce some of the world's best-loved brands including ROYAL CANIN(R), PEDIGREE(R), WHISKAS(R), CESAR(R), M&M'S(R), SNICKERS(R), EXTRA(R), Pringles(R), Cheez-It(R) and BEN'S ORIGINAL(TM). Our international networks of pet hospitals, including BANFIELD(TM), BLUEPEARL(TM), VCA(TM) and ANICURA(TM) deliver high quality veterinary care and ANTECH (TM) offers breakthrough capabilities in pet diagnostics.
For more information about Mars, please visit www.mars.com. Join us on Facebook, Instagram, LinkedIn and YouTube.
*/ To participate and for full offer terms and conditions, visit CESAR.com/JustEatCesar.
* * *
Original text here: https://www.mars.com/news-and-stories/press-releases-statements/cesar-brand-lacey-chabert-just-eat-cesar-pink-pack
[Category: BizFood/Beverage]
* * *
The CESAR(R) brand and Lacey Chabert declare: We should totally "Just Eat CESAR!" with limited-edition Pink Pack
Ahead of the October 3rd pop-culture tradition that has fans seeing pink, the CESAR brand and Lacey Chabert are finally making fetch happen with a nutritious glow-up for dogs' everyday mealtime
Here's the hot gossip:
- What is the "Just Eat CESAR!" Campaign? The "Just Eat CESAR!" campaign is a playful partnership between the CESAR(R) brand and Lacey Chabert, giving dogs a starring ... Show Full Article MCLEAN, Virginia, Sept. 16 -- CESAR, a part of Mars Inc., issued the following news release: * * * The CESAR(R) brand and Lacey Chabert declare: We should totally "Just Eat CESAR!" with limited-edition Pink Pack Ahead of the October 3rd pop-culture tradition that has fans seeing pink, the CESAR brand and Lacey Chabert are finally making fetch happen with a nutritious glow-up for dogs' everyday mealtime Here's the hot gossip: - What is the "Just Eat CESAR!" Campaign? The "Just Eat CESAR!" campaign is a playful partnership between the CESAR(R) brand and Lacey Chabert, giving dogs a starringrole in the pop culture celebration of October 3. Through exclusive videos and social content, Lacey brings the campaign to life, alongside the launch of the exclusive, limited-edition CESAR Pink Pack, featuring varieties that showcase the color pink in their packaging. The 12-pack features three complete and balanced recipes: Classic Loaf in Sauce Porterhouse Steak Flavor, Filets in Gravy Prime Rib Flavor and Classic Loaf in Sauce Smoked Bacon & Egg Flavor, offering wholesome, nutritious CESAR wet food for everyday mealtime.
- When and where can pet parents get the CESAR Pink Pack? The limited-edition CESAR Pink Pack will be available for free on a first-come, first-served basis exclusively on Wednesday, September 16 and Wednesday, September 23 at CESAR.com/JustEatCesar while supplies last./*
- How can fans celebrate from anywhere? From September 16-23, 2026, fans are encouraged to celebrate in their own way by taking part in one or more of the following: sharing their own pink-inspired CESAR moments with their dog on Instagram and TikTok using #CESARShare, engaging with exclusive social content from Lacey Chabert, claiming the Pink Pack at CESAR.com/JustEatCesar, or earning rewards through Go Fetch Rewards on the Fetch App.
FRANKLIN, Tenn. (Sept. 15, 2026) - Every fall, one of the internet's most beloved pop culture traditions takes over social media as fans celebrate October 3 with iconic quotes, pink fashion and nostalgic throwbacks. This year, the CESAR(R) brand is joining forces with actress, mom and dog lover Lacey Chabert to give dogs their own starring role in the fun.
Known for her iconic role as an unapologetic, pink-clad trendsetter famous for spilling secrets, Lacey and the CESAR brand are putting a fresh, furry spin on one of cinema's most legendary rants, declaring: We should totally "Just Eat CESAR!" The playful, social-first campaign celebrates dogs, mealtime and the everyday bond they share with the people who love them, headlined by the launch of the limited-edition CESAR Pink Pack, created for pet parents who embody the spirit of Love Like Crazy(TM).
"While Wednesdays will always belong to the color pink, CESAR cuisine provides wholesome, nutritious meals dogs deserve every day," said Lacey Chabert. "We shouldn't save the good stuff for a rare treat! As a dog lover, I'm thrilled to help the CESAR brand show pet parents that giving their dogs high-quality food is the best daily routine."
The CESAR brand and Lacey Chabert bring the campaign to life this fall with exclusive drops of the CESAR Pink Pack on Wednesday, September 16 and Wednesday, September 23 at CESAR.com/JustEatCesar, because on Wednesdays (and every day), dogs should Just Eat CESAR!/*
The limited-edition CESAR Pink Pack invites pet parents and their dogs to become cafeteria royalty with a 12-pack bundle featuring tongue-out tasty CESAR wet food recipes, including:
- Classic Loaf in Sauce Porterhouse Steak Flavor
- Filets in Gravy Prime Rib Flavor
- Classic Loaf in Sauce Smoked Bacon & Egg Flavor
Crafted with high-quality, purposeful ingredients, each recipe delivers a 100% complete and balanced nutrition, making the CESAR brand a wholesome, delicious meal dogs deserve every day.
"We're thrilled to unveil the re-energized visual identity for our brand - a fresh glow-up of our logo, beloved Westie dog, and new signature color: pink," said Lina Tinsley, Brand Director for CESAR U.S. "With this new campaign, we're bringing that pink identity to life, giving pet parents a fun new way to celebrate a pop culture moment and show their dogs extra love. Because at its heart, CESAR is all about flavorful variety, quality nutrition, and delightful shared experiences."
The celebration doesn't stop with the Pink Pack.
Lacey Chabert will bring the drama (the good kind!) to social media through a series of exclusive social videos, giving fans a front-row seat to see what makes the CESAR brand the queen bee of pet food with its slow-cooked and perfectly balanced recipes.
Fans are encouraged to claim the exclusive drop and share their own, pink-inspired moments with their dog -- whether it's a CESAR Pink Pack, a pink pup accessory, or their dog's best "posse" post. Fans can tag @cesardogfood_us on Instagram and @cesardogfood on TikTok using #CESARShare to officially join the "Just Eat CESAR!" squad.
Every CESAR Pink Pack also includes an insert card linking directly to Go Fetch Rewards on the Fetch App, where pet parents can earn points and unlock rewards for their pups./*
* * *
About Mars, Incorporated
Mars, Incorporated is driven by the belief that the world we want tomorrow starts with how we do business today. Based on combined Mars and Kellanova 2025 net sales, we are a $65bn+ family-owned business with 170,000 Associates, our diverse portfolio of leading pet care products and veterinary services serve pets all around the world and our quality snacking and food products delights millions of people every day. We produce some of the world's best-loved brands including ROYAL CANIN(R), PEDIGREE(R), WHISKAS(R), CESAR(R), M&M'S(R), SNICKERS(R), EXTRA(R), Pringles(R), Cheez-It(R) and BEN'S ORIGINAL(TM). Our international networks of pet hospitals, including BANFIELD(TM), BLUEPEARL(TM), VCA(TM) and ANICURA(TM) deliver high quality veterinary care and ANTECH (TM) offers breakthrough capabilities in pet diagnostics.
For more information about Mars, please visit www.mars.com. Join us on Facebook, Instagram, LinkedIn and YouTube.
*/ To participate and for full offer terms and conditions, visit CESAR.com/JustEatCesar.
* * *
Original text here: https://www.mars.com/news-and-stories/press-releases-statements/cesar-brand-lacey-chabert-just-eat-cesar-pink-pack
[Category: BizFood/Beverage]
Baker Donelson Expands Equipment Finance Team With Addition of Nationally Recognized Attorney Ken Weinberg
MEMPHIS, Tennessee, Sept. 16 -- Baker Donelson, a law firm, issued the following news release:
* * *
Baker Donelson Expands Equipment Finance Team with Addition of Nationally Recognized Attorney Ken Weinberg
Experienced Asset-Based Financing Transactions Attorney Jennifer Howard Also Joins, Furthering Firm's Commercial Equipment Leasing and Finance Capabilities
-
Baker Donelson has expanded its Equipment Finance Team with the addition of Ken Weinberg, a nationally recognized attorney in the equipment leasing and finance industry.
Mr. Weinberg joins as a shareholder in the Firm's Birmingham ... Show Full Article MEMPHIS, Tennessee, Sept. 16 -- Baker Donelson, a law firm, issued the following news release: * * * Baker Donelson Expands Equipment Finance Team with Addition of Nationally Recognized Attorney Ken Weinberg Experienced Asset-Based Financing Transactions Attorney Jennifer Howard Also Joins, Furthering Firm's Commercial Equipment Leasing and Finance Capabilities - Baker Donelson has expanded its Equipment Finance Team with the addition of Ken Weinberg, a nationally recognized attorney in the equipment leasing and finance industry. Mr. Weinberg joins as a shareholder in the Firm's Birminghamoffice. Joining alongside Mr. Weinberg is attorney Jennifer Howard, further strengthening Baker Donelson's capabilities in commercial equipment leasing and finance, asset-based lending, and energy finance.
These deeply experienced attorneys are significant additions to a practice that serves clients across the equipment finance industry and related sectors, expanding the team's ability to support clients in increasingly sophisticated transactions.
"As one of the preeminent practitioners in the field of equipment finance, Ken has spent decades helping shape the industry through his leadership and service to his clients," said Patton Hahn, managing shareholder of Baker Donelson's Birmingham office. "His arrival, along with Jennifer's, significantly expands the depth of our Equipment Finance Team. Their experience strengthens our ability to provide practical counsel across a broad range of equipment finance and energy-related matters."
Mr. Weinberg focuses his practice exclusively on commercial equipment leasing and finance transactions and is widely recognized within the industry as a leader in his field, providing counsel to some of the largest equipment leasing and finance companies in the United States. His experience spans a broad range of transactions, including various lease structures; equipment finance agreements and traditional loan transactions; progress payment, interim funding, and construction financings; vendor lease programs; assignments and syndications; warehouse and funding lines; refinancings; back-leveraging transactions; lease assignments; sales of interests; and portfolio acquisitions. He also advises lenders, investors, and developers on energy financing transactions involving solar facilities, biomass facilities, landfill-gas-to-energy projects, and natural-gas-fired plants.
Ms. Howard advises clients across the country on asset-based financing transactions, with a focus on equipment finance and energy generation project finance. Her experience includes all phases of structuring and documenting true leases, leases intended as secured financings, and equipment loans involving a variety of equipment types. She also advises clients in connection with construction loans, term loans, and other financings related to energy generation facilities, including anaerobic digesters, landfill-gas-to-energy facilities, solar facilities, and natural-gas-fired plants.
"Ken's practice is highly complementary to the work we are already doing across our financial services transactions practice," said Kevin P. LaTulip Jr., head of Baker Donelson's Financial Services Transactions Group. "He brings substantial experience across the full spectrum of equipment leasing and finance transactions, as well as a strong skill set in developing AI-enabled client service tools, which complements the Firm's focus on innovation and client service delivery. Combined with Jennifer's background, these additions build on a well-established practice and position the team to handle a broader range of sophisticated transactions, enhancing our ability to serve existing and new clients."
Mr. Weinberg, who joins from CM Law, previously practiced with Baker Donelson and has remained actively involved in the equipment leasing and finance industry throughout his career. In addition to representing participants in equipment finance transactions nationwide, he has served as an expert witness in equipment leasing and finance litigation matters across the country and is known for his work developing practical solutions to complex transaction issues.
"I am excited to be returning home to Baker Donelson, where I have spent the majority of my career," said Mr. Weinberg. "The Firm provides a platform that allows Jennifer and me to continue building a dedicated equipment finance team while drawing on the capabilities of a full-service law firm. The breadth of the Firm's practices creates opportunities to help clients with a wider range of business and legal needs and to pursue larger and more complex transactions. Baker Donelson's dedication to innovation will also accelerate our development and deployment of tools and processes that enhance the client experience - something the equipment leasing and finance industry, built on efficiency and practicality, has always valued."
Mr. Weinberg was the recipient of the Equipment Leasing and Finance Association's 2023 Edward A. Groobert Award for Legal Excellence, the highest honor awarded by the organization to an attorney, and is recognized in The Best Lawyers in America(R) for Banking and Finance Law. He previously served both on the Legal Committee of the Equipment Leasing and Finance Association and as co-chair of the association's Energy Subcommittee. Mr. Weinberg is the author of "Dispatches from the Trenches," a regular column published in the Monitor since 2002. He also serves on the editorial board of the Equipment Leasing Newsletter published by Law Journal Newsletters and regularly presents on equipment leasing and finance topics nationwide.
Mr. Weinberg and Ms. Howard, who are both licensed to practice in Alabama, are both graduates of the University of Georgia School of Law and Vanderbilt University.
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Original text here: https://www.bakerdonelson.com/baker-donelson-expands-equipment-finance-team-with-addition-of-nationally-recognized-attorney-ken-weinberg
[Category: BizLaw/Legal]
* * *
Baker Donelson Expands Equipment Finance Team with Addition of Nationally Recognized Attorney Ken Weinberg
Experienced Asset-Based Financing Transactions Attorney Jennifer Howard Also Joins, Furthering Firm's Commercial Equipment Leasing and Finance Capabilities
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Baker Donelson has expanded its Equipment Finance Team with the addition of Ken Weinberg, a nationally recognized attorney in the equipment leasing and finance industry.
Mr. Weinberg joins as a shareholder in the Firm's Birmingham ... Show Full Article MEMPHIS, Tennessee, Sept. 16 -- Baker Donelson, a law firm, issued the following news release: * * * Baker Donelson Expands Equipment Finance Team with Addition of Nationally Recognized Attorney Ken Weinberg Experienced Asset-Based Financing Transactions Attorney Jennifer Howard Also Joins, Furthering Firm's Commercial Equipment Leasing and Finance Capabilities - Baker Donelson has expanded its Equipment Finance Team with the addition of Ken Weinberg, a nationally recognized attorney in the equipment leasing and finance industry. Mr. Weinberg joins as a shareholder in the Firm's Birminghamoffice. Joining alongside Mr. Weinberg is attorney Jennifer Howard, further strengthening Baker Donelson's capabilities in commercial equipment leasing and finance, asset-based lending, and energy finance.
These deeply experienced attorneys are significant additions to a practice that serves clients across the equipment finance industry and related sectors, expanding the team's ability to support clients in increasingly sophisticated transactions.
"As one of the preeminent practitioners in the field of equipment finance, Ken has spent decades helping shape the industry through his leadership and service to his clients," said Patton Hahn, managing shareholder of Baker Donelson's Birmingham office. "His arrival, along with Jennifer's, significantly expands the depth of our Equipment Finance Team. Their experience strengthens our ability to provide practical counsel across a broad range of equipment finance and energy-related matters."
Mr. Weinberg focuses his practice exclusively on commercial equipment leasing and finance transactions and is widely recognized within the industry as a leader in his field, providing counsel to some of the largest equipment leasing and finance companies in the United States. His experience spans a broad range of transactions, including various lease structures; equipment finance agreements and traditional loan transactions; progress payment, interim funding, and construction financings; vendor lease programs; assignments and syndications; warehouse and funding lines; refinancings; back-leveraging transactions; lease assignments; sales of interests; and portfolio acquisitions. He also advises lenders, investors, and developers on energy financing transactions involving solar facilities, biomass facilities, landfill-gas-to-energy projects, and natural-gas-fired plants.
Ms. Howard advises clients across the country on asset-based financing transactions, with a focus on equipment finance and energy generation project finance. Her experience includes all phases of structuring and documenting true leases, leases intended as secured financings, and equipment loans involving a variety of equipment types. She also advises clients in connection with construction loans, term loans, and other financings related to energy generation facilities, including anaerobic digesters, landfill-gas-to-energy facilities, solar facilities, and natural-gas-fired plants.
"Ken's practice is highly complementary to the work we are already doing across our financial services transactions practice," said Kevin P. LaTulip Jr., head of Baker Donelson's Financial Services Transactions Group. "He brings substantial experience across the full spectrum of equipment leasing and finance transactions, as well as a strong skill set in developing AI-enabled client service tools, which complements the Firm's focus on innovation and client service delivery. Combined with Jennifer's background, these additions build on a well-established practice and position the team to handle a broader range of sophisticated transactions, enhancing our ability to serve existing and new clients."
Mr. Weinberg, who joins from CM Law, previously practiced with Baker Donelson and has remained actively involved in the equipment leasing and finance industry throughout his career. In addition to representing participants in equipment finance transactions nationwide, he has served as an expert witness in equipment leasing and finance litigation matters across the country and is known for his work developing practical solutions to complex transaction issues.
"I am excited to be returning home to Baker Donelson, where I have spent the majority of my career," said Mr. Weinberg. "The Firm provides a platform that allows Jennifer and me to continue building a dedicated equipment finance team while drawing on the capabilities of a full-service law firm. The breadth of the Firm's practices creates opportunities to help clients with a wider range of business and legal needs and to pursue larger and more complex transactions. Baker Donelson's dedication to innovation will also accelerate our development and deployment of tools and processes that enhance the client experience - something the equipment leasing and finance industry, built on efficiency and practicality, has always valued."
Mr. Weinberg was the recipient of the Equipment Leasing and Finance Association's 2023 Edward A. Groobert Award for Legal Excellence, the highest honor awarded by the organization to an attorney, and is recognized in The Best Lawyers in America(R) for Banking and Finance Law. He previously served both on the Legal Committee of the Equipment Leasing and Finance Association and as co-chair of the association's Energy Subcommittee. Mr. Weinberg is the author of "Dispatches from the Trenches," a regular column published in the Monitor since 2002. He also serves on the editorial board of the Equipment Leasing Newsletter published by Law Journal Newsletters and regularly presents on equipment leasing and finance topics nationwide.
Mr. Weinberg and Ms. Howard, who are both licensed to practice in Alabama, are both graduates of the University of Georgia School of Law and Vanderbilt University.
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Original text here: https://www.bakerdonelson.com/baker-donelson-expands-equipment-finance-team-with-addition-of-nationally-recognized-attorney-ken-weinberg
[Category: BizLaw/Legal]
Akerman Advises B. Riley Securities and D.A. Davidson & Co. on CPI Secondary Offering of Common Stock by Selling Stockholders
MIAMI, Florida, Sept. 16 -- Akerman, a law firm, issued the following news release:
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Akerman Advises B. Riley Securities and D.A. Davidson & Co. on CPI Secondary Offering of Common Stock by Selling Stockholders
Akerman represented B. Riley Securities and D.A. Davidson & Co. in the registered underwritten secondary public offering of common stock of CPI Card Group Inc. (Nasdaq: PMTS) by certain stockholders. The aggregate size of the offering was 2,687,921 shares of the company's common stock, including 350,598 shares sold pursuant to full exercise of the underwriters' option to purchase ... Show Full Article MIAMI, Florida, Sept. 16 -- Akerman, a law firm, issued the following news release: * * * Akerman Advises B. Riley Securities and D.A. Davidson & Co. on CPI Secondary Offering of Common Stock by Selling Stockholders Akerman represented B. Riley Securities and D.A. Davidson & Co. in the registered underwritten secondary public offering of common stock of CPI Card Group Inc. (Nasdaq: PMTS) by certain stockholders. The aggregate size of the offering was 2,687,921 shares of the company's common stock, including 350,598 shares sold pursuant to full exercise of the underwriters' option to purchaseadditional shares, at the public offering price of $21.50 per share.
Total gross proceeds from the offering to the selling stockholders, before deducting the underwriting discount and other estimated offering expenses, including the exercise of the underwriters' option to purchase additional shares, were approximately $57.8 million.
B. Riley Securities and D.A. Davidson & Co. acted as joint book-running managers for the offering. Lake Street Capital Markets acted as co-manager for the offering.
The Akerman team advising B. Riley Securities and D.A. Davidson & Co. was led by Corporate Practice Group Co-Chair Christina C. Russo, Corporate Practice Group Partner Tara A. Jackson, and Corporate Practice Group Associates Amanda C. Rementeria and Arielle Flamenbaum, and included key support across the firm's national platform from:
- Christy S. Hawkins, Partner, Consumer Financial Services, Data and Technology (CFS+) Practice Group
- Robert Loewy, Partner, Tax Practice Group
- Esther L. Moreno, Chair, Capital Markets Practice
- Ryan Roman, Partner, Litigation Practice Group
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About Akerman
Founded in 1920, Akerman is an Am Law 100 firm recognized by Vault among the nation's most prestigious law firms. The firm has more than 700 lawyers and business professionals throughout the United States.
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URL: B. Riley Securities
URL: D.A. Davidson & Co.
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Original text here: https://www.akerman.com/en/firm/newsroom/akerman-advises-b-riley-securities-and-da-davidson-and-co-on-cpi-secondary-offering-of-common-stock-by-selling-stockholders.html
[Category: BizLaw/Legal]
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Akerman Advises B. Riley Securities and D.A. Davidson & Co. on CPI Secondary Offering of Common Stock by Selling Stockholders
Akerman represented B. Riley Securities and D.A. Davidson & Co. in the registered underwritten secondary public offering of common stock of CPI Card Group Inc. (Nasdaq: PMTS) by certain stockholders. The aggregate size of the offering was 2,687,921 shares of the company's common stock, including 350,598 shares sold pursuant to full exercise of the underwriters' option to purchase ... Show Full Article MIAMI, Florida, Sept. 16 -- Akerman, a law firm, issued the following news release: * * * Akerman Advises B. Riley Securities and D.A. Davidson & Co. on CPI Secondary Offering of Common Stock by Selling Stockholders Akerman represented B. Riley Securities and D.A. Davidson & Co. in the registered underwritten secondary public offering of common stock of CPI Card Group Inc. (Nasdaq: PMTS) by certain stockholders. The aggregate size of the offering was 2,687,921 shares of the company's common stock, including 350,598 shares sold pursuant to full exercise of the underwriters' option to purchaseadditional shares, at the public offering price of $21.50 per share.
Total gross proceeds from the offering to the selling stockholders, before deducting the underwriting discount and other estimated offering expenses, including the exercise of the underwriters' option to purchase additional shares, were approximately $57.8 million.
B. Riley Securities and D.A. Davidson & Co. acted as joint book-running managers for the offering. Lake Street Capital Markets acted as co-manager for the offering.
The Akerman team advising B. Riley Securities and D.A. Davidson & Co. was led by Corporate Practice Group Co-Chair Christina C. Russo, Corporate Practice Group Partner Tara A. Jackson, and Corporate Practice Group Associates Amanda C. Rementeria and Arielle Flamenbaum, and included key support across the firm's national platform from:
- Christy S. Hawkins, Partner, Consumer Financial Services, Data and Technology (CFS+) Practice Group
- Robert Loewy, Partner, Tax Practice Group
- Esther L. Moreno, Chair, Capital Markets Practice
- Ryan Roman, Partner, Litigation Practice Group
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About Akerman
Founded in 1920, Akerman is an Am Law 100 firm recognized by Vault among the nation's most prestigious law firms. The firm has more than 700 lawyers and business professionals throughout the United States.
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URL: B. Riley Securities
URL: D.A. Davidson & Co.
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Original text here: https://www.akerman.com/en/firm/newsroom/akerman-advises-b-riley-securities-and-da-davidson-and-co-on-cpi-secondary-offering-of-common-stock-by-selling-stockholders.html
[Category: BizLaw/Legal]