Businesses
Here's a look at documents from U.S. and international businesses
Featured Stories
TikTok Launches Behind The Breakthrough With Sienna Spiro
LOS ANGLES, California, May 19 -- TikTok, a destination for a short-form mobile video, issued the following news:
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TikTok launches Behind The Breakthrough with SIENNA SPIRO
TikTok is excited to unveil the latest campaign in its Behind the Breakthrough series with SIENNA SPIRO and her smash hit 'Die On This Hill'.
SIENNA SPIRO first started to use TikTok to build her audience in 2024 when she released 'MAYBE.', which generated over a million creations. She followed this up in 2025 with 'You Stole the Show', which generated over 2 million creations and over 3 billion video views on TikTok,
... Show Full Article
LOS ANGLES, California, May 19 -- TikTok, a destination for a short-form mobile video, issued the following news:
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TikTok launches Behind The Breakthrough with SIENNA SPIRO
TikTok is excited to unveil the latest campaign in its Behind the Breakthrough series with SIENNA SPIRO and her smash hit 'Die On This Hill'.
SIENNA SPIRO first started to use TikTok to build her audience in 2024 when she released 'MAYBE.', which generated over a million creations. She followed this up in 2025 with 'You Stole the Show', which generated over 2 million creations and over 3 billion video views on TikTok,becoming her real breakthrough moment, and putting her firmly on the world stage.
She then released 'Die On This Hill', which became an unequivocal global sensation, driven by the TikTok community, with over 6 million creations and 16 billion video views. It was the most-saved track over the last 12 months worldwide on TikTok, and sparked a wave of performance-led trends, inspired by the power of her lyrics and emotional storytelling, including memory montages and high-profile covers, with performances by P!NK, Demi Lovato, and SIENNA's own duet with Sam Smith.
Fueled by this momentum, "Die On This Hill" translated into significant off-platform success, generating more than 385 million streams on Spotify and charting at #19 on the Billboard Hot 100. SIENNA has garnered critical acclaim from Rolling Stone, Wonderland, Dazed, V Magazine, The New York Times, and many more, been tipped as an "Artist to Watch" for 2026 from the likes of Billboard, Stereogum, Pigeons & Planes, and shortlisted for the BRIT Awards' highly esteemed Critics' Choice of 2026 award. She was recently named on Forbes "30 Under 30" Europe list and received two American Music Award nominations for Best Vocal Performance and Breakthrough Pop Artist.
SIENNA's most recent fan-demanded hit single, 'The Visitor', further built on that momentum. The track has been used in over 2 million TikTok creations and generated more than 3 billion video views, while her headline "The Visitor Tour" was met with widespread praise and sold out across North America, the UK, and Europe.
Behind the Breakthrough is a documentary-style series that captures TikTok breakout artists reflecting on how their music and careers have been transformed by the platform and its community. The series has already featured Gigi Perez's 'Sailor Song', Malcolm Todd's 'Chest Pain (I Love)', and Alex Warren's huge hit smash 'Ordinary'.
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Original text here: https://newsroom.tiktok.com/tiktok-launches-behind-the-breakthrough-with-sienna-spiro?lang=en
[Category: BizMedia]
Ian P. Faria Quoted in The Wall Street Journal on Rising Construction-Defect Lawsuits Against Major U.S. Homebuilders
BIRMINGHAM, Alabama, May 19 -- Bradley, a law firm, issued the following news release:
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Ian P. Faria Quoted in The Wall Street Journal on Rising Construction-Defect Lawsuits Against Major U.S. Homebuilders
Bradley partner Ian P. Faria was quoted in The Wall Street Journal arguing that aggressive plaintiffs' attorneys are helping drive the wave of litigation, rather than widespread builder misconduct.
According to Faria, plaintiff attorneys in new developments often go "door-to-door," identifying possible defects and encouraging homeowners to sue.
Once lawyers recruit "one or two takers,"
... Show Full Article
BIRMINGHAM, Alabama, May 19 -- Bradley, a law firm, issued the following news release:
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Ian P. Faria Quoted in The Wall Street Journal on Rising Construction-Defect Lawsuits Against Major U.S. Homebuilders
Bradley partner Ian P. Faria was quoted in The Wall Street Journal arguing that aggressive plaintiffs' attorneys are helping drive the wave of litigation, rather than widespread builder misconduct.
According to Faria, plaintiff attorneys in new developments often go "door-to-door," identifying possible defects and encouraging homeowners to sue.
Once lawyers recruit "one or two takers,"they send letters throughout the neighborhood urging additional homeowners to join lawsuits.
Faria's comments reflect the builders' legal defense narrative: that construction-defect litigation is being actively cultivated by plaintiffs' firms seeking large settlements, even as homeowners describe serious structural and health-related problems in their homes.
The full article, "Home Builders Are Getting Buried in Claims of Shoddy Construction," (https://www.wsj.com/real-estate/home-builders-are-getting-buried-in-claims-of-shoddy-construction-346e4a05?mod=e2li) was published by The Wall Street Journal on May 18, 2026. (login required)
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Original text here: https://www.bradley.com/insights/news/2026/05/ian-faria-quoted-in-the-wall-street-journal-on-rising-constructiondefect-lawsuits-against-major-us
[Category: BizLaw/Legal]
Gartner Says Chief Supply Chain Officers Must Shift to an Autonomous Business Mindset
STAMFORD, Connecticut, May 19 (TNSrep) -- Gartner, an information technology research and advisory company, issued the following news release:
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Gartner Says Chief Supply Chain Officers Must Shift to an Autonomous Business Mindset
Analysts Discuss Impact of Applying Autonomy Across Supply Chains at Gartner Supply Chain Symposium/Xpo
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Chief supply chain officers (CSCOs) must prepare for a new era of business in which decision-making and execution increasingly shift from siloed automation to outcome-driven autonomy, according to Gartner, Inc., a business and technology insights company.
During
... Show Full Article
STAMFORD, Connecticut, May 19 (TNSrep) -- Gartner, an information technology research and advisory company, issued the following news release:
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Gartner Says Chief Supply Chain Officers Must Shift to an Autonomous Business Mindset
Analysts Discuss Impact of Applying Autonomy Across Supply Chains at Gartner Supply Chain Symposium/Xpo
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Chief supply chain officers (CSCOs) must prepare for a new era of business in which decision-making and execution increasingly shift from siloed automation to outcome-driven autonomy, according to Gartner, Inc., a business and technology insights company.
Duringthe Opening Keynote at Gartner Supply Chain Symposium/Xpo in Barcelona, attendees learned how autonomous business capabilities are beginning to reshape supply chain strategy and execution, and the distinct implications for supply chains.
Autonomous business is defined by Gartner as a strategy that uses self-improving, adaptable technology to make decisions, take action and create new types of value by increasing both people autonomy and machine autonomy. In supply chains, this represents a significant change because digital intelligence must be coordinated with physical execution across complex networks of factories, warehouses and transportation assets.
"As autonomous business becomes the dominant model for how organizations run, CSCOs must rethink not just how work gets done, but who is making the decisions. They must decide if it's people, machines or both," said Alan O'Keeffe, VP Analyst in Gartner's Supply Chain practice. "This is a shift from optimizing tasks to orchestrating outcomes, with clear guardrails that balance machine autonomy with human leadership."
Supply Chains Are Entering the Autonomous Business Era
A Gartner survey of 469 global CEOs and senior business leaders from March tp November 2025 found that 8 in 10 executives expect autonomous business to become the dominant form of business by 2030. For supply chain organizations, this shift is quickly moving from experimentation to competitive expectation, as customers increasingly evaluate partners based on their ability to build autonomous capabilities.
Autonomy in supply chain is fundamentally different from other business functions, due to the complexity of moving physical goods where constraints are real, execution is variable, and disruptions can ripple quickly across the system. This complexity is what makes the shift significant.
To prepare, Gartner emphasized three readiness priorities for CSCOs:
* Move operations from task automation focused on optimizing for speed to outcome-based decision flows.
* Strengthen intelligence with governance, guardrails and context that allow autonomy to scale safely.
* Evolve the workforce so teams can oversee, improve and collaborate with AI-enabled systems across the network.
"This is not a 'set it and forget it' technology story," O'Keeffe said. "The winners will be the supply chains that design for autonomy in the real world, where physical operations, risk tolerance and accountability matter as much as algorithms."
More information on building an autonomous supply chain can be found here: The AI-Native Supply Chain (https://www.gartner.com/en/supply-chain/trends/ai-native-supply-chain).
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Gartner is the World Authority on AI
Gartner is an indispensable partner to C-Level executives and technology providers as they implement AI strategies to achieve their mission-critical priorities. The independence and objectivity of Gartner insights provide clients with the confidence to make informed decisions and unlock the full potential of AI. Clients across the C-Level are using Gartner's proprietary AskGartner AI tool to determine how to leverage AI in their business. With more than 2,500 business and technology experts, 6,000 written insights, as well as more than 4,000 AI use cases and case studies, Gartner is the world authority on AI. More information can be found here.
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About Gartner Supply Chain Symposium/Xpo
Gartner Supply Chain Symposium/Xpo is the world's most important gathering of CSCOs and supply chain executives. Explore how CSCOs predict disruptions, achieve visibility, and lead with AI and innovation. Gain insights from Gartner experts and peers on rethinking models, integrating technology and designing resilient, future-ready supply chains.
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About the Gartner Supply Chain Practice
The Gartner Supply Chain Practice provides actionable, objective insights for supply chain leaders and their teams, so they can respond to disruption and innovate for the future through leading-edge supply chain management practices.
Additional information is available at https://www.gartner.com/en/supply-chain. Follow news and updates from the Gartner Supply Chain Practice on LinkedIn and X using #GartnerSC. Visit the Gartner Supply Chain Newsroom for more information and insights.
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Original text here: https://www.gartner.com/en/newsroom/press-releases/2026-05-18-gartner-says-chief-supply-chain-officers-must-shift-to-an-autonomous-business-mindset
[Category: BizConsulting]
Fisher Phillips Issues Insight: EU Overhauls AI Act Just Before Key Deadline - What Should Businesses Do With The Extra Time?
ATLANTA, Georgia, May 19 -- Fisher Phillips, a law firm, issued the following insight on May 18, 2026:
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EU Overhauls AI Act Just Before Key Deadline: What Should Businesses Do With The Extra Time?
With a critical compliance deadline just months away, European Union lawmakers and member states reached a provisional agreement on 7 May to significantly overhaul the EU AI Act, changes that promise relief for the business community. The revisions will push back enforcement of high-risk AI rules by 16 months, strip overlapping requirements that created duplicate compliance burdens for manufacturers,
... Show Full Article
ATLANTA, Georgia, May 19 -- Fisher Phillips, a law firm, issued the following insight on May 18, 2026:
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EU Overhauls AI Act Just Before Key Deadline: What Should Businesses Do With The Extra Time?
With a critical compliance deadline just months away, European Union lawmakers and member states reached a provisional agreement on 7 May to significantly overhaul the EU AI Act, changes that promise relief for the business community. The revisions will push back enforcement of high-risk AI rules by 16 months, strip overlapping requirements that created duplicate compliance burdens for manufacturers,and extend regulatory relief to a broader array of smaller businesses. Importantly, for employers using AI to hire, monitor, or manage workers in the EU, this means the compliance deadline for high-risk AI systems used in employment decisions just moved from August 2026 to December 2027. What do companies doing business in the EU need to know?
Check out our primer on the EU AI Act here: The 7 Things You Need to Know About the EU's AI Act.
Employment Rules Delayed Until Late 2027
The European Parliament and Council of the EU reached the provisional agreement to reform the EU AI Act as part of a broader "Digital Omnibus on AI" simplification package. The deal was driven by mounting pressure from industry groups and member states - particularly Germany - that warned the original compliance framework was becoming unworkable, especially for manufacturers facing duplicative requirements across multiple EU laws.
The biggest change for employers pushes back enforcement of rules covering high-risk AI systems in areas such as employment, biometrics, critical infrastructure, education, migration, and border control until December 2, 2027 - a 16-month delay from the previous August 2, 2026, deadline. For AI systems that qualify as regulated products or safety components, the deadline is extended to August 2, 2028.
Bias Detection and Special Category Data
The reform clarifies that organizations may process special category data (e.g., race, health, or sexual orientation) where strictly necessary for bias detection and correction in in both high-risk and non-high-risk AI systems, expanding the legal basis to cover providers and deployers. Safeguards like pseudonymization and access controls remain mandatory, and the strict necessity standard stays intact.
Five More Changes Businesses Should Know About
Beyond the deadline extension, the agreement makes several other notable adjustments:
* Industrial and product-embedded AI gets relief. The deal clarifies that machinery products only need to comply with sectoral safety rules rather than both the EU AI Act and sectoral rules. The European Commission will also be able to limit the EU AI Act's application in other sectors (including medical devices, toys, and connected cars) where existing sectoral law already contains similar AI-specific requirements.
* Definition of "safety component" gets tightened. The agreement clarifies the term "safety component," meaning AI systems that only assist users or optimize performance will not automatically face high-risk obligations under the AI Act if their failure or malfunction does not create health or safety risks.
* SME relief extended to small mid-caps. The deal extends some regulatory exemptions that were previously provided to Small and Medium-sized Enterprises (SMEs) to small mid-cap companies as well.
* AI-generated content transparency deadline adjusted. The application of watermarking obligations on AI-generated content has been delayed until December 2, 2026, so companies using generative AI tools to produce content have a few extra months to implement labeling solutions.
* High-risk database registration reinstated. Notably, the update brings back the obligation for providers to register AI systems in the EU's high-risk systems database, including for providers that believe their systems qualify for an exemption from the high-risk classification.
One New Prohibition to Know About
The provisional agreement adds a new prohibition on AI systems that create child sexual abuse material or that depict, without that person's consent, the intimate parts of an identifiable person or an identifiable person engaged in sexually explicit activities. Compliance with this prohibition begins December 2, 2026.
What's Next
The European Parliament and the Council must now formally adopt the provisional agreement, with formal adoption expected before the current August 2 deadline when the current rules on high-risk AI systems would otherwise become applicable. Upon adoption, the amendments will be published in the EU's Official Journal and enter into force three days later.
What Do Businesses Need to Do?
Keep in mind that this deal doesn't change the AI Act's fundamental architecture. High-risk AI in employment and other sensitive categories is still regulated, and transparency obligations are still coming. But it does give companies more time, reduce overlap for industrial and product-embedded AI, and narrow the definitional scope so fewer systems get swept in inadvertently. Use the extended timeline to:
* Audit your AI systems to identify which ones fall under the high-risk framework, paying particular attention to tools used in hiring, performance evaluation, workforce monitoring, and termination decisions;
* Map your AI vendors and determine whether they are providers or deployers under the Act, since your compliance obligations differ significantly depending on your role;
* Review contracts with AI vendors to confirm they will meet their own obligations under the Act before the new deadlines arrive;
* Begin building a compliance gameplan now, even with the extended timeline -- because December 2027 will arrive faster than you think; and
* Monitor the formal adoption process expected before August 2, since the amendments don't take effect until published in the EU's Official Journal. The best way to track developments is to ensure you are subscribed to Fisher Phillips' Insight System to gather the most up-to-date information directly to your inbox.
Conclusion
If you have questions, contact your Fisher Phillips attorney, the author of this Insight, or any attorney in our AI, Data, and Analytics Practice Group or our International Practice Group. Make sure you subscribe to Fisher Phillips' Insight System to gather the most up-to-date information on AI and the workplace.
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Related People
Mauricio Foeth
Of Counsel
+52 55 48992148/+49 1575 8880464
mfoeth@fisherphillips.mx
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Nan Sato, CIPP/E, CIPP/C
Regional Managing Partner, Tokyo
+81-3-6892-5595
nsato@fisherphillips.com
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Original text here: https://www.fisherphillips.com/en/insights/insights/eu-overhauls-ai-act-just-before-key-deadline
[Category: BizLaw/Legal]
Baxfendy Approved in the U.S. as the First and Only Aldosterone Synthase Inhibitor Treatment for Adults With Fypertension
WILMINGTON, Delaware, May 19 -- AstraZeneca, a biopharmaceutical company, issued the following news release:
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BAXFENDY approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension
Approval based on BaxHTN Phase III results showing statistically significant and
clinically meaningful reduction in systolic blood pressure in patients with
uncontrolled or resistant hypertension
BAXFENDY 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-
adjusted) from baseline in BaxHTN trial
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AstraZeneca's BAXFENDY(TM) (baxdrostat) has
... Show Full Article
WILMINGTON, Delaware, May 19 -- AstraZeneca, a biopharmaceutical company, issued the following news release:
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BAXFENDY approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension
Approval based on BaxHTN Phase III results showing statistically significant and
clinically meaningful reduction in systolic blood pressure in patients with
uncontrolled or resistant hypertension
BAXFENDY 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-
adjusted) from baseline in BaxHTN trial
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AstraZeneca's BAXFENDY(TM) (baxdrostat) hasbeen approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.
There are 1.4 billion people worldwide living with hypertension.1 In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive medications still struggle with persistently elevated blood pressure,2 which is a leading risk factor for cardiovascular disease and premature death.3,4 Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk.5-7
BAXFENDY is a first-in-class, highly selective and potent ASI designed to lower blood pressure in a new way by specifically inhibiting the production of aldosterone,8 a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems.9-11
The approval by the US Food and Drug Administration (FDA) was based on positive results from the BaxHTN Phase III trial,12 with BAXFENDY demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2mg and 1mg doses in patients with uncontrolled and resistant hypertension on two or more medications. BAXFENDY was generally well-tolerated with no unanticipated safety findings.
Dr. Bryan Williams, Chair of Medicine at University College London, and BaxHTN primary investigator, said: "We have been waiting for an innovative medication like BAXFENDY for hypertension for many years. Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension. In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with BAXFENDY is exciting and clinically meaningful for clinicians and patients. Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events."
John M. Clymer, Executive Director, National Forum for Heart Disease & Stroke Prevention, said: "Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage and dementia. Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney and brain health."
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: "The approval of BAXFENDY offers a much needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines. In the US, about 23 million patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades."
In the BaxHTN Phase III trial,13 published in the New England Journal of Medicine,12 BAXFENDY (baxdrostat) demonstrated statistically significant and clinically meaningful efficacy for the treatment of patients with hypertension on top of standard of care. At week 12, the absolute reduction from baseline in mean seated SBP was 15.7 mmHg (95% confidence interval [CI], -17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95% CI, -12.6 to -7.0; p<0.001) for the 2mg dose. For the 1mg dose, the absolute reduction from baseline was 14.5 mmHg (95% CI, -16.5 to -12.5) and placebo-adjusted reduction was 8.7 mmHg (95% CI, -11.5 to -5.8; p<0.001). The reduction in mean seated SBP with placebo was 5.8 mmHg (95% CI, -7.9 to -3.8). Results were consistent across both uncontrolled and treatment-resistant subgroups.
IMPORTANT SAFETY INFORMATION for BAXFENDY(TM) (baxdrostat)
Warnings and Precautions
Hyperkalemia
BAXFENDY can cause hyperkalemia. Assess serum potassium prior to initiation of BAXFENDY and monitor periodically during treatment. Correct serum potassium abnormalities prior to initiation. More frequent monitoring is recommended for patients at increased risk of hyperkalemia (eg, patients 65 years of age, those with diabetes mellitus or chronic kidney disease, and those receiving concomitant medications that increase serum potassium). If hyperkalemia occurs, treat hyperkalemia and consider interrupting or discontinuing BAXFENDY. Consider more frequent monitoring in patients who restart BAXFENDY after experiencing hyperkalemia. Permanently discontinue if clinically significant hyperkalemia recurs.
Hyponatremia
BAXFENDY can cause hyponatremia. Assess serum sodium prior to initiation and monitor
periodically during treatment. Correct serum sodium abnormalities prior to initiation. More
frequent monitoring is recommended for patients with low baseline serum sodium
concentrations and those at risk for hyponatremia. If clinically significant hyponatremia occurs, treat the hyponatremia and consider interrupting or discontinuing BAXFENDY. Consider more frequent monitoring of serum sodium in patients who restart BAXFENDY after experiencing hyponatremia. Permanently discontinue if clinically significant hyponatremia recurs.
Adverse Reactions
Most frequently reported adverse reactions (2% with BAXFENDY and greater (1%) than placebo in pooled, placebo-controlled trials) reported for BAXFENDY 1 mg and 2 mg, respectively, were hyperkalemia (6.6%, 10.2%), hypotension (2.1%, 3.6%), hyponatremia (2.1%, 3.2%), dizziness (3.0%, 2.9%), and muscle spasms (1.8%, 2.9%).
Drug Interactions
Drugs That Increase Serum Potassium: Monitor serum potassium more frequently when BAXFENDY is used concomitantly with drugs that impair potassium secretion or increase serum potassium. Concomitant use may increase the risk of hyperkalemia.
Strong and moderate CYP3A inducers: Monitor the therapeutic effect of BAXFENDY more frequently during concomitant use. BAXFENDY is a CYP3A substrate.
INDICATION for BAXFENDY(TM) (baxdrostat)
BAXFENDY is an aldosterone synthase inhibitor indicated, in combination with other antihypertensive drugs, for the treatment of hypertension to lower blood pressure in adults who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Dosing
The recommended dosage of BAXFENDY is 2 mg orally once daily. For patients at increased risk of hyperkalemia or hyponatremia, the recommended dosage is 1 mg orally once daily.
Please see accompanying US Full Prescribing Information for BAXFENDY, including Patient Information.
You may report side effects related to AstraZeneca products.
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Notes
Uncontrolled hypertension
Hypertension is a medical condition characterized by consistently high blood pressure levels, affecting an estimated 1.4 billion people worldwide.1,14,15 Over time, this can damage blood vessels and vital organs, increasing the risk of serious health problems such as heart attack, stroke, heart failure and kidney disease.14,15
Treated but uncontrolled patients with hypertension are at a significantly greater risk of all-cause mortality, heart-disease specific mortality, stroke-related mortality, CVD-specific mortality and dementia than patients whose hypertension is controlled. A large meta-analysis found that lowering systolic blood pressure by 10 mmHg can reduce the risk of major adverse cardiovascular events by around 20%,16 underscoring the urgent need for new treatments that target a key hypertension pathway at its source.
An observational study of nearly 60,000 patients studied over a median of 9.7 years showed that a 9.5 mmHg increase in SBP was associated with a 30% increase in risk of all-cause mortality and 41% increase in risk of cardiovascular death.17 Studies have shown that increased night-time blood pressure is associated with higher cardiovascular risk,18,19 and patients with hypertension have a higher risk of cardiovascular events like heart attack, stroke and death around the time of their morning blood pressure surge.20,21
Aldosterone, a hormone that raises blood pressure to unhealthy levels by promoting sodium and water retention9,10 is a key contributor to persistently uncontrolled hypertension. Elevated aldosterone levels, along with factors such as obesity, high salt intake, and various genetic or secondary conditions,22 are strongly associated with poor blood pressure control and the progression of heart failure and kidney disease. When left untreated, hypertension significantly increases the risk of cardiovascular and kidney-related complications.5,14,23
BaxHTN trial
The BaxHTN Phase III trial13 had three components to it that supported the following endpoints. The primary endpoint was assessed during a 12-week double-blind, placebo-controlled period. A total of 796 patients were characterized in a 1:1:1 ratio to receive BAXFENDY 2mg, 1mg or placebo once daily on top of standard of care [2 antihypertensive agents at baseline, one of which is a diuretic for uncontrolled hypertension and 3 antihypertensive agents at baseline, one of which is a diuretic for resistant hypertension].The primary efficacy endpoint was the difference in mean change from baseline in seated SBP at week 12 between participants treated with baxdrostat (2mg or 1mg separately) and participants treated with placebo. Persistence of efficacy was assessed during a randomized withdrawal period from week 24 to week 32. Approximately 300 patients treated with BAXFENDY 2mg were re-randomized in a 2:1 ratio to either continue receiving baxdrostat 2mg or placebo for the 8 weeks. SBP at the end of the 8 weeks was compared with placebo and the BAXFENDY 2mg dose. Long-term safety was assessed at the end of the 52 weeks compared to a standard of care arm.
Additional confirmatory secondary endpoints include the effect of BAXFENDY versus placebo on seated SBP at week 12 in the resistant hypertension subpopulation, the effect of BAXFENDY versus placebo on seated diastolic blood pressure at week 12, and proportion of participants achieving seated SBP less than 130 mmHg at week 12.
BAXFENDY and the clinical development program
BAXFENDY is a first-in-class, highly selective and potent, oral, small molecule that inhibits aldosterone synthase,8 an enzyme encoded by the CYP11B2 gene, which is responsible for the synthesis of aldosterone in the adrenal gland.10 In clinical trials, BAXFENDY was observed to significantly lower aldosterone levels without affecting cortisol levels across a wide range of doses.24,25
As part of a broad development program, BAXFENDY is currently being investigated in clinical trials in other conditions where high aldosterone plays a role in elevating cardiorenal risk, including as a monotherapy for primary aldosteronism,26 and in combination with dapagliflozin for chronic kidney disease and hypertension,27,28 and the prevention of heart failure in patients with hypertension.29 Additional clinical data for BAXFENDY in hypertension includes positive data from the Bax24 Phase III trial,30 which showed a statistically significant and highly clinically meaningful placebo-adjusted reduction of 24-hour ambulatory systolic blood pressure in patients with resistant hypertension, with full results published in The Lancet.31
AstraZeneca acquired BAXFENDY through its purchase of CinCor Pharma, Inc. in February 2023.32
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AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of AstraZeneca's main disease areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys, liver and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection by slowing or stopping disease progression, and ultimately paving the way towards regenerative therapies. The Company's ambition is to improve and save the lives of millions of people, by better understanding the interconnections between CVRM diseases and targeting the mechanisms that drive them, so we can detect, diagnose and treat people earlier and more effectively.
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AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. The contents of AstraZeneca's website do not form part of this document and no one should rely on such websites or the contents thereof in reading this document.
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References
1. World Health Organization. Global report on hypertension 2025: high stakes: turning evidence into action. 2025. https://iris.who.int/handle/10665/382841. Accessed September 2025.
2. Carey RM, et al. Prevalence of Apparent Treatment-Resistant Hypertension in the United States. Hypertension.2019;73(2):424-431.
3. Rapsomaniki E, et al. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014 May 31;383(9932):1899-911.
4. GBD 2019 Risk Factors Collaborators. Lancet. 2020;396:1223-1249.
5. Zhou D, et al. Uncontrolled hypertension increases risk of all-cause and cardiovascular disease mortality in US adults: the NHANES III Linked Mortality Study. Sci Rep. 2018: 20;8(1):9418.
6. Hall ME et al. Weight-loss strategies for prevention and treatment of hypertension: a scientific statement from the American Heart Association. Hypertension. 2021;78:e38-e50.
7. GBD 2023 Disease and Injury and Risk Factor Collaborators. Burden of 375 diseases and injuries, risk-attributable burden of 88 risk factors, and healthy life expectancy in 204 countries and territories, including 660 subnational locations, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023. Lancet. 2025;406:1873-1922.
8. Bogman K, et al. Preclinical and early clinical profile of a highly selective and potent oral inhibitor of aldosterone synthase (CYP11B2). Hypertension. 2017;69:189-96.
9. Inoue K, et al. Serum aldosterone concentration, blood pressure, and coronary artery calcium: the Multi-Ethnic Study of Atherosclerosis [including online supplement]. Hypertension. 2020;76(1):113-120.
10. Cannavo A, et al. Aldosterone and mineralocorticoid receptor system in cardiovascular physiology and pathophysiology. Oxid Med Cell Longev. 2018;2018:1204598.
11. Xanthakis V, Vasan RS. Aldosterone and the risk of hypertension. Curr Hypertens Rep. 2013;15(2):102-107.
12. Flack JM, et al. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. N Engl J Med. 2025. Aug 30:10.1056/NEJMoa2507109. doi: 10.1056/NEJMoa2507109.
13. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxHTN). Available at: https://clinicaltrials.gov/study/NCT06034743. Accessed April 2026.
14. McEvoy JW, et al. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. EurHeart J. 2024;45(38):3912-4018.
15. Whelton PK, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71(6):1269-1324.
16. Ettehad, D. et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis; Lancet 2016;387:957-67.
17. Staplin N, et al. Relationship between clinic and ambulatory blood pressure and mortality: an observational cohort study in 59124 patients. Lancet. 2023;401(10393):2041-2050.
18. Narita K, et al. Nighttime Home Blood Pressure Is Associated With the Cardiovascular Disease Events Risk in Treatment-Resistant Hypertension. Hypertension. 2022;79(2):e18-e20
19. Niiranen TJ, Maki J, Puukka P, Karanko H, Jula AM. Office, home, and ambulatory blood pressures as predictors of cardiovascular risk. Hypertension. 2014 Aug;64(2):281-6.
20. Renna NF, et al. Morning blood pressure surge as a predictor of cardiovascular events in patients with hypertension. Blood Press Monit. 2023;28(3):149-157
21. Kario K et al. Morning hypertension: the strongest independent risk factor for stroke in elderly hypertensive patients. Hypertens Res. 2006;29(8):581-7.
22. van Oort S, et al. Association of cardiovascular risk factors and lifestyle behaviors with hypertension: a mendelian randomization study. Hypertension. 2020;76(6):1971-1979.
23. Jones DW, et al. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2025;152:e114-e218.
24. Freeman MW, et al. Results from a phase 1, randomized, double-blind, multiple ascending dose study characterizing the pharmacokinetics and demonstrating the safety and selectivity of the aldosterone synthase inhibitor baxdrostat in healthy volunteers. Hypertens Res. 2023;46(1):108-118.
25. Freeman MW, et al. Phase 2 trial of baxdrostat for treatment-resistant hypertension. N Engl J Med. 2023;388(5):395-405.
26. ClinicalTrials.gov. A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism (BaxPA). Available at: https://clinicaltrials.gov/study/NCT07007793. Accessed April 2026.
27. ClinicalTrials.gov. A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. Available at: https://clinicaltrials.gov/study/NCT06268873. Accessed April 2026.
28. ClinicalTrials.gov. A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure (BaxDuo-Pacific). Available at: https://clinicaltrials.gov/study/NCT06742723. Accessed April 2026.
29. ClinicalTrials.gov. Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin (Prevent-HF). Available at: https://clinicaltrials.gov/study/NCT06677060. Accessed April 2026.
30. ClinicalTrials.gov. A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension (Bax24). Available at: https://clinicaltrials.gov/study/NCT06168409. Accessed April 2026.
31. Azizi M, Bax24 investigators, et al. Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2026 Mar 7;407(10532):988-999.
32. AstraZeneca 2023. Acquisition of CinCor Pharma complete. Available at: https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html. Accessed April 2026.
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Original text here: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/BAXFENDY-approved-in-the-US-as-the-first-and-only-aldosterone-synthase-inhibitor-treatment-for-adults-with-hypertension.html
[Category: BizPharmaceuticals]
Advent Appoints Patricia Cross, AM as an Operating Partner in Australia and New Zealand
BOSTON, Massachusetts, May 19 -- Advent International, a private equity investor, issued the following news release on May 18, 2026:
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Advent appoints Patricia Cross, AM as an Operating Partner in Australia and New Zealand
Sydney - Advent, a leading global private equity investor, today announced the appointment of Patricia Cross, AM as an Operating Partner in Australia and New Zealand. Patricia brings more than 40 years of management and board-level experience in financial services including wealth management, investment / asset management and corporate and institutional banking. Patricia
... Show Full Article
BOSTON, Massachusetts, May 19 -- Advent International, a private equity investor, issued the following news release on May 18, 2026:
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Advent appoints Patricia Cross, AM as an Operating Partner in Australia and New Zealand
Sydney - Advent, a leading global private equity investor, today announced the appointment of Patricia Cross, AM as an Operating Partner in Australia and New Zealand. Patricia brings more than 40 years of management and board-level experience in financial services including wealth management, investment / asset management and corporate and institutional banking. Patriciawill work closely with Advent's investment professionals and portfolio company leadership teams to support governance, strategic direction and long-term value creation across the firm's investments in the region.
Beau Dixon, Managing Director and Head of Australia and New Zealand at Advent, said, "Patricia brings an exceptional depth of sector knowledge and governance expertise, with a career that spans the full breadth of financial services. Her perspective will be highly valuable to our investment professionals and portfolio company leadership teams as we continue to build our presence in the region."
Patricia Cross, Operating Partner at Advent, said, "I am delighted to be joining Advent as an Operating Partner and to be part of such a committed global network of investment professionals and industry specialists. Financial services is a sector undergoing profound change, and I look forward to working alongside Advent's teams to help portfolio companies navigate that environment, strengthen their strategic positioning, and drive sustainable growth."
Patricia has extensive international experience as both an executive and non-executive director across a wide range of financial services, with particular expertise in capital markets, risk management, corporate governance, treasury, portfolio management and international affairs. Over the course of her career, she has directly managed large, complex businesses and during the last 25 years Patricia has served on nine large cap listed company boards in Australia and the United Kingdom.
She currently serves as Chairperson of ASX-listed OFX Limited and as an Independent Non-Executive Director of ASX-listed Transurban Limited. She recently finished her 5-year term as a Member of the Future Fund Board of Guardians, Australia's sovereign wealth fund. Previous ASX and LSE listed board roles include Independent Non-Executive Director at Macquarie Group, National Australia Bank, AMP, Qantas Airways, Wesfarmers, and Aviva plc. Patricia formerly served as the Chairperson of Commonwealth Superannuation Corporation, which is responsible for managing super funds designed specifically for Australian Government and Defence Force employees.
In addition to Patricia's Chairperson and Independent Non-Executive Director experience, she lived and worked in seven different countries holding a number of senior executive leadership positions including with Chase Manhattan Bank and Chase Investment Bank, Banque Nationale de Paris, and National Australia Bank.
With more than 145 Operating Partners and Operations Advisors globally, Patricia joins Advent's extensive network of industry experts who provide specialised sector and operational insight to support the growth of Advent's portfolio companies.
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About Advent
Advent is a leading global private equity investor committed to working in partnership with management teams, entrepreneurs, and founders to help transform businesses. With 16 offices across five continents, we oversee more than USD $102 billion in assets under management/* and have made 448 investments across 44 countries.
Since our founding in 1984, we have developed specialist market expertise across our five core sectors: business & financial services, consumer, healthcare, industrial, and technology. This approach is bolstered by our deep sub-sector knowledge, which informs every aspect of our investment strategy, from sourcing opportunities to working in partnership with management to execute value creation plans. We bring hands-on operational expertise to enhance and accelerate businesses.
As one of the largest privately-owned partnerships, our 655 colleagues leverage the full ecosystem of Advent's global resources, including our Portfolio Support Group, insights provided by industry expert Operating Partners and Operations Advisors, as well as bespoke tools to support and guide our portfolio companies as they seek to achieve their strategic goals.
To learn more, visit our website or connect with us on LinkedIn.
*/ Assets under management (AUM) as of December 31, 2025. AUM includes assets attributable to Advent advisory clients as well as employee and third-party co-investment vehicles.
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Original text here: https://www.adventinternational.com/news/advent-appoints-patricia-cross-am-as-an-operating-partner-in-australia-and-new-zealand/
[Category: BizFinancial Services]
APS Rate Case Hearing Begin
PHOENIX, Arizona, May 19 -- Arizona Public Service Co. issued the following news on May 18, 2026:
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APS Rate Case Hearing Begins; Final Decision to Come Later This Year
Today marks the start of the evidentiary hearing in the Arizona Public Service (APS) rate case before the Arizona Corporation Commission (ACC). This hearing is the latest step in a lengthy open and transparent rate review process that started in June 2025 and will likely continue through the end of 2026.
Why is APS requesting a rate increase?
Current APS rates are based on costs from five years ago. Inflation and rising
... Show Full Article
PHOENIX, Arizona, May 19 -- Arizona Public Service Co. issued the following news on May 18, 2026:
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APS Rate Case Hearing Begins; Final Decision to Come Later This Year
Today marks the start of the evidentiary hearing in the Arizona Public Service (APS) rate case before the Arizona Corporation Commission (ACC). This hearing is the latest step in a lengthy open and transparent rate review process that started in June 2025 and will likely continue through the end of 2026.
Why is APS requesting a rate increase?
Current APS rates are based on costs from five years ago. Inflation and risingexpenses mean those rates no longer cover what it takes to operate and strengthen the electric grid today. By updating rates to reflect current costs, APS can continue to provide customers with the top-tier reliability they need and expect, especially during Arizona's long, hot summers.
As a regulated utility, APS must look backward to adjust its rates based on the actual costs it paid to serve customers in 2024 and 2025. This ensures rates more accurately match the true costs of providing electric service to customers. For context, over the past five years, APS has experienced rapidly rising costs of equipment needed to deliver power to customers. One example is transformer costs which are, on average, 49-90% higher now than when our rates were last set. (See graphic below.)
How does the rate proposal protect affordability and reliability for APS customers?
In addition to ensuring a reliable energy grid and upgrading equipment, the rate case introduces measures to further support customers. Amid rising costs for infrastructure, equipment and materials, APS is anticipating unprecedented growth within its service territory. To protect residential and small business customers, APS is making sure new large energy users, like data centers, continue to pay their full cost of service.
The plan proposes a rate increase of more than 45% increase for data centers and updated cost allocation for system investments, like power plants, so growth-related costs are assigned to the customer classes driving expansion. APS's application also outlines a formula rate, under which future costs (e.g., infrastructure, fuel, etc.) are reviewed annually and allocated to the customer group responsible for those costs, such as data centers.
What comes next?
During the hearing, which is expected to last just over a month, APS and other parties (known as intervenors), will present evidence, answer questions and provide on-the-record testimony about energy grid investments APS made in 2024 and 2025 to enable top-tier reliability for its customers. No rate adjustments will occur until the rate case process is complete.
In the months after the hearing concludes:
* The ACC's Administrative Law Judge will consider the evidence presented and issue a Recommended Opinion and Order (ROO) for the Commission's consideration.
* APS and intervenors will have an opportunity to file exceptions or responses to the ROO.
* The ACC will publicly review and vote on the case. A final decision is expected toward the end of the year. If approved, a rate adjustment would follow.
What about summer electric bills?
With the arrival of hotter weather, most customers will naturally use more energy as air conditioners work harder to keep homes cool. That higher energy usage in the summer drives higher bills for most customers. APS's rate proposal will have zero impact on customer bills this summer.
It's important for customers to know they have options to manage their bills and lower their costs. For example, customers can compare rate plans by using APS's rate comparison tool at aps.com/compare. Customers can visit aps.com/save for tips to save energy.
Customer Support and Resources
APS helps connect customers facing financial hardship to programs and resources that can make a difference. The Crisis Bill Assistance program provides up to $1,000 for those in need. Eligible customers can also receive monthly discounts of up to 25% or 60% through the APS Energy Support program. Learn more at aps.com/assistance or by calling the 24/7 Customer Care Center. APS advisors are available in English and Spanish at 602-371-7171 or 800-253-9405.
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APS serves 1.5 million homes and businesses in 11 of Arizona's 15 counties and is a leader in safely delivering reliable, affordable electricity in the Southwest. APS maintains a diverse range of energy resources, including nuclear from the Palo Verde Generating Station, natural gas, coal, solar, wind and energy storage - a mix that's about 58% clean. With 140 years of experience serving Arizona, APS is the main subsidiary of Pinnacle West Capital Corp. (NYSE: PNW).
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Original text here: https://www.aps.com/en/About/Our-Company/Newsroom/Articles/APS-Rate-Case-Hearing-Begins
[Category: BizEnergy]
