Omada Health to Present Real-World Evidence at ObesityWeek 2025 Demonstrating Enhanced Outcomes for Current and Former GLP-1 Users




Omada Health to Present Real-World Evidence at ObesityWeek 2025 Demonstrating Enhanced Outcomes for Current and Former GLP-1 Users

Results suggest sustained, long-term impact of Omada’s program on weight loss and longer medication persistence

SAN FRANCISCO, Nov. 04, 2025 (GLOBE NEWSWIRE) — Omada Health (Nasdaq: OMDA), the virtual between-visit healthcare provider, announced it will present two posters at ObesityWeek 2025 highlighting the potential impact of Omada’s behavior change program on members currently or previously on GLP-1 medications for weight loss. Together, these analyses suggest that engagement with Omada may enhance results for members who have been on GLP-1s for weight loss, whether they stay on the medication or not.

Previous clinical studies have suggested that sustained weight loss leads to increased long-term health benefits,¹ including the reduction of comorbidities, and persistence on a GLP-1 is associated with greater weight loss.² Those who stop GLP-1s tend to regain the weight they lost³ on the medication. Omada’s analyses demonstrated the clinical benefit of its wraparound lifestyle program on members at various stages of GLP-1 usage.

Omada Increased GLP-1 Medication Persistence and Weight Loss
The first analysis examined GLP-1 persistence rates of 1,124 Omada members enrolled in Omada’s Enhanced GLP-1 Care Track, which provides tailored support to members on their GLP-1 journey.

The analysis evaluated Omada members at 12 and 24 weeks in the program, examining how factors such as program engagement impacted members’ medication persistence. While real-world evidence has previously found lower GLP-1 persistence rates⁴ compared to clinical trials,⁵ Omada’s analysis demonstrated that support via Omada’s program supported enhanced persistence commensurate with increased engagement; 84% of participants stayed on their medication for 24 weeks and lost more weight than those who stopped earlier (12.1% vs. 7.4%). It also found that for every 10 additional engagements per week in the initial 12 weeks, the odds of medication persistence were 54% higher.

“These findings underscore a critical insight in the evolving landscape of obesity treatment. While GLP-1s are powerful tools, our research demonstrates that lifestyle support programs, like Omada, can enhance their effectiveness,” said Sarah Linke, PhD, MPH, Senior Director, Clinical & Translational Research, Omada Health.

Omada Members Maintained Sustained Weight Lost 12 months Post-Discontinuation
The second analysis looked at weight change during the discontinuation phase of the GLP-1 journey. The team conducted a retrospective analysis using prescription claims to examine 816 total Omada members without type 2 diabetes, evaluating them at 6, 9, and/or 12 months after GLP-1 discontinuation. It found that, at one year post-discontinuation, members (n=95) experienced 0.8% average weight change,⁶ compared to 11-12% weight gain typically seen in clinical trials,⁷ with 63.2% maintaining or continuing to lose weight at 12 months.

“As channels to access GLP-1s increase and healthcare costs rise,⁸ every dollar invested into patient care counts,” said Wei-Li Shao, President, Omada Health. “These analyses demonstrated that engagement with Omada may enhance the effectiveness of GLP-1 therapy across all stages of treatment – helping to optimize outcomes and reduce wasted financial investment.”

These studies were completed as part of the Omada Insights Lab ANSWERS (ANalyzing Success of WEight medication with Real-world evidence and Stats) Initiative, which examines and shares real-world data from Omada’s behavior change weight health programs.

Both posters will be presented at The Obesity Society’s ObesityWeek 2025 in Atlanta on November 4-5, 2025.

Omada Health
Omada Health is a virtual-first healthcare provider that nurtures lifelong health, one day at a time. Omada care teams implement clinically-validated behavior change protocols for individuals living with diabetes, hypertension, prediabetes, and musculoskeletal issues. With more than a decade of experience and data, and 30 peer-reviewed publications that showcase its clinical and economic results, Omada is designed to help improve health outcomes and contain healthcare costs. Omada’s scope exceeds 2,000 customers, including health plans, health systems, and employers ranging in size from small businesses to Fortune 500s.

The foundation of Omada’s success is a strong, vibrant work culture, which helped earn the company the distinction of becoming an officially certified Great Place to Work^®. An industry leader, Omada was the first virtual provider to join the Institute for Healthcare Improvement’s Leadership Alliance, reflecting the aim to complement primary care providers for the benefit of members, and affirming its guarantee to every partner: Omada works differently.

Great Place to Work^® is the registered trademark of the Great Place to Work Institute and is used under license.

Contacts
Rose Ramseth
press@omadahealth.com

¹ Ryan DH, Yockey SR. Weight Loss and Improvement in Comorbidity: Differences at 5%, 10%, 15%, and Over. Curr Obes Rep. 2017;6(2):184-194. doi: 10.1007/s13679-017-0262-y

² Gasoyan H, Butsch WS, Schulte R, et al. Changes in weight and glycemic control following obesity treatment with semaglutide or tirzepatide by discontinuation status. Obesity. 2025;33(9):1657-1667. doi:10.1002/oby.24331

³Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. 2024;331(1):38-48. doi:10.1001/jama.2023.24945

⁴Gasoyan H, Pfoh ER, Schulte R, et al. Early- and later-stage persistence with antiobesity medications: A retrospective cohort study. Obesity. 2024;32(3):486-493. doi:10.1002/oby.23952

⁵Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021;384:989-1002. doi:10.1056/NEJMoa2032183

⁶Chang H, Devaraj SM, Naqvi JB, Napoleone J, Linke S. Weight maintenance is possible after GLP-1s—with the right support. Omada Health. Published September 8, 2025. Accessed October 2025. https://resourcecenter.omadahealth.com/white-papers/weight-maintenance-is-possible-after-glp-1s-with-the-right-support.

⁷Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. 2024;331(1):38-48. doi:10.1001/jama.2023.24945

⁸Umland B, Patel S. Employers prepare for the highest health benefit cost increase in 15 years. Mercer. Published September 3, 2025. Accessed October 2025. https://www.mercer.com/en-us/insights/us-health-news/employers-prepare-for-the-highest-health-benefit-cost-increase-in-15-years/

Rivus Pharmaceuticals Presents Preclinical Data for Controlled Metabolic Accelerator (CMA) Pipeline Showing Fat-Selective, Muscle-Preserving Weight Loss in Obesity at ObesityWeek®




Rivus Pharmaceuticals Presents Preclinical Data for Controlled Metabolic Accelerator (CMA) Pipeline Showing Fat-Selective, Muscle-Preserving Weight Loss in Obesity at ObesityWeek®

First data from Rivus’ preclinical CMA pipeline showing potential as monotherapy and in combination with GLP-1s

CHARLOTTESVILLE, Va. and SOUTH SAN FRANCISCO, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) — Rivus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to treating obesity and associated cardiometabolic diseases, today announced that a poster of the first data from the company’s preclinical pipeline of oral Controlled Metabolic Accelerators (CMAs) will be presented at ObesityWeek^® organized by The Obesity Society (TOS) being held November 4-7, 2025 in Atlanta, GA.

“Obesity is a chronic disease for which chronic treatment options are urgently needed to achieve sustained weight loss and address this unprecedented epidemic. We are incredibly encouraged by these preclinical data, which demonstrate our CMA’s potential to not only achieve greater weight loss, but also to do so while preserving lean muscle mass,” said Shaharyar Khan, Ph.D., Chief Scientific Officer, Rivus Pharmaceuticals. “In addition, this preclinical study showed that combining our oral CMA with GLP-1s may offer an improved profile to enable chronic use. These findings represent an important proof-of-concept for our preclinical CMA pipeline as we work to advance a new class of oral medicines targeting obesity and the associated cardiometabolic diseases.”

In preclinical studies, Rivus evaluated RV201 (ANT activator, investigational oral small molecule) as a single agent and in combination with semaglutide. Data demonstrated RV201 drives fat-selective, muscle-preserving weight loss after 8 days in a preclinical model of obesity:

• Weight loss: Greater weight loss for RV201 treatment groups
  • -16% for RV201 monotherapy
  • -15% (high dose) and -2% (low dose) for semaglutide monotherapy
  • -25% (high dose) and -22% (low dose) for semaglutide with RV201 combination therapy
  • After treatment stopped, weight loss was stable for 6 days for both RV201 treatment groups
• Fat loss: Greater fat loss for RV201 treatment groups
  • -46% for RV201 monotherapy
  • -24% (high dose) and -7% (low dose) for semaglutide monotherapy
  • -63% (high dose) and -57% (low dose) for semaglutide with RV201 combination therapy
• Lean muscle mass: Preserved for RV201 treatment groups
• Energy expenditure: Increased for RV201 treatment groups
  • RV201 monotherapy and in combination with semaglutide resulted in increased energy expenditure without increasing body temperature
  • Semaglutide monotherapy significantly reduced energy expenditure and food intake

Presentation details are as follows:

Abstract Title: Oral Controlled Metabolic Accelerator Drives Fat-Specific Weight Loss and Augments GLP-1 Effect
Abstract Number: 121
Format: Poster Presentation
Presenter: Sol Collado, Ph.D., Senior Director, Drug Discovery, Rivus Pharmaceuticals
Presentation Date and Time: Tuesday, November 4, 2025, 7:30 – 8:30 p.m. ET

A copy of the ObesityWeek preclinical data poster will be accessible at the start of the poster session under “Clinical Data and Scientific Publications” in Our Science section of Rivus’ website.

About Controlled Metabolic Accelerators (CMAs)
Rivus is advancing a new class of oral medicines called Controlled Metabolic Accelerators (CMAs) for obesity and associated cardiometabolic diseases. Rivus’ CMAs are designed to induce sustained, fat-selective, muscle-preserving weight loss. These oral small molecule therapeutics are engineered to safely increase resting metabolic rate and result in increased energy expenditure primarily from fat. Leveraging the natural metabolic process of mitochondrial uncoupling, CMAs increase the resting metabolic rate in a manner that is precision-controlled, in clinical trials to date, and imperceptible to the patient. Rivus’ lead CMA HU6 is in Phase 2 clinical development and its pipeline of CMAs in preclinical development includes the RV300 family (dual ANT-GLP-1 pharmacology). 

About Rivus Pharmaceuticals
Rivus Pharmaceuticals, Inc. is a clinical-stage biotechnology company advancing novel medicines for obesity and associated cardiometabolic diseases. A leader in mitochondrial biology, Rivus is developing a new class of investigational therapies called Controlled Metabolic Accelerators (CMAs), which are oral small molecules designed for sustained, fat-selective, muscle-preserving weight loss. Rivus’ lead candidate HU6 (ANT activator) has demonstrated positive results in three Phase 2 clinical trials across MASH (metabolic dysfunction associated steatohepatitis), MASLD (metabolic dysfunction-associated steatotic liver disease) and HFpEF (heart failure with preserved ejection fraction). In addition to HU6, Rivus is developing a pipeline of preclinical CMAs. Follow Rivus on LinkedIn and X and visit www.rivuspharma.com.

Company Contact: 
Amy Figueroa, CFA
Rivus Pharmaceuticals
afigueroa@rivuspharma.com

Media Contact:
Meredith Mallen
Real Chemistry
mmallen@realchemistry.com

Aardvark Therapeutics Presents Data Supporting its Metabolic Obesity Pipeline Programs at ObesityWeek 2025




Aardvark Therapeutics Presents Data Supporting its Metabolic Obesity Pipeline Programs at ObesityWeek 2025

New preclinical results demonstrate the potential of ARD-201 in enhanced glucose control, along with preservation of lean mass, underscoring its opportunity in addressing key challenges in today’s obesity treatment landscape 

Preclinical and clinical data demonstrates the potential of ARD-201 to attenuate weight gain, promote weight loss and help maintain weight after the discontinuation of GLP-1RA

Aardvark to host investor webinar on November 5th, 2025 to review ARD-101 and ARD-201 programs, as well as ObesityWeek presentations

SAN DIEGO, Nov. 04, 2025 (GLOBE NEWSWIRE) — Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, presented data today at the ObesityWeek 2025 conference demonstrating the mechanistic rationale and therapeutic potential of two of its metabolic obesity programs, including ARD-201.

“More than 50% of patients stop taking GLP-1 therapies within 3 months, often resulting in rapid weight regain,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “ARD-201 combines the noted anti-hunger and metabolic effects of ARD-101 with the synergistic properties of sitagliptin to enhance the anti-appetite effects of ARD-101 to create a potential first-in-class therapy that may overcome the tolerability and rebound challenges of GLP-1 therapies. We’re looking forward to advancing ARD-201 into two Phase 2 trials, POWER and STRENGTH, to further evaluate its potential for individuals living with metabolic obesity.”

ARD-201 Obesity Program
ARD-201 is planned to be a fixed-dose combination of the TAS2R agonist ARD-101 and the DPP-4 inhibitor sitagliptin. The co-administration of these two compounds will be tested in the Phase 2 POWER Trial (Prevention Of WEight Regain) expected to commence by the end of 2025.

Poster Title: TAS2R Agonist ARD-101 Attenuates Weight Gain in Mice and Reduces Hunger in Adults with Obesity

Summary: Preclinical and clinical data support the continued development of ARD-201 to attenuate weight gain, promote weight loss, and help maintain weight after the discontinuation of glucagon-like peptide-1 receptor agonist (GLP-1RA) therapies. In addition, ARD-201 improved glucose tolerance and lean body mass composition.

Notable findings:

• Preclinical – ARD-201 (Validated Diet-Induced Obesity (DIO) Mouse Model):
  • ARD-201 reduced fat mass comparable to high-dose tirzepatide but, unlike tirzepatide, preserved lean mass
  • ARD-201 alone achieved glucose control comparable to high-dose tirzepatide, and in combination with low-dose tirzepatide delivered the most rapid glucose clearance
  • Previously reported preclinical data demonstrated ARD-201 reduced body weight by ~19% after 30 days, which was comparable to high-dose tirzepatide
  • Previously reported preclinical data demonstrated ARD-201 ~30% weight loss when combined low-dose tirzepatide
• Clinical – ARD-101 (Randomized, Placebo-Controlled, Phase 2A Study in Adults with Obesity):
  • ARD-101 showed signals of weight control, reduced hunger, and improved metabolic parameters, particularly among participants with elevated baseline values
  • ARD-101 was well tolerated, with no serious adverse events or treatment discontinuations, reflecting a distinct profile from the effects associated with current anti-obesity therapies

WE-868 Obesity Program
WE-868 is a small molecule isoflavonoid designed to modulate oxidative phosphorylation and represents a potentially novel pathway for promoting weight loss and additional metabolic benefits.

Poster Title: An Isoflavonoid Modulator of Oxidative Metabolism with Therapeutic Potential in Obesity and Diabetes

Summary: A clinical study of WE-868 showed a correlation between treatment and weight loss in patients in another indication, and subsequent preclinical studies explored the mechanism as a novel treatment for obesity. An additional preclinical study showed that WE-868 shifts cellular energy metabolism by modulating oxidative phosphorylation.

Notable findings:

• In preclinical studies, WE-868 dose-dependently prevented high-fat diet (HFD)-induced weight gain, with the higher dose inducing net weight loss
• In DIO mice, significant weight loss was seen in medium and high dose WE-868 compared to semaglutide

Aardvark to Host an Investor Webinar on November 5

Aardvark will host an investor webinar on Wednesday, November 5^th, 2025 from 5:00 p.m. to 7:00 p.m. ET to provide an overview of ARD-101, ARD-201 and WE-868 data presented at ObesityWeek. The event will feature a discussion with leading key opinion leaders Tony Lam, Ph.D., Professor at the University of Toronto, and Caroline Apovian, M.D., Co-Director at Center for Weight Management and Wellness at Brigham and Women’s Hospital. The event will also feature a discussion on ARD-101 in Prader-Willi Syndrome with Stacy Ward, MS, BCBA, Chief Executive Officer of Prader-Willi Syndrome Association – USA, and Dorothea Lantz, Director of Community Engagement at Prader-Willi Syndrome Association – USA.

The live webcast presentation will be accessible on the company’s website, https://ir.aardvarktherapeutics.com/news-events/events, under the investors section, and an archived recording will be available on the website following the presentation.

About ARD-101
ARD-101 is a gut-restricted small molecule agonist of select taste receptors (TAS2Rs) expressed on the luminal side of the intestine. As a potent bitter taste receptor pan-agonist, ARD-101 stimulates enteroendocrine cells of the digestive tract to release multiple gut-peptide hormones including GLP-1 and the satiety hormone cholecystokinin (CCK), which activates gut-brain neurologic signaling to mediate hunger. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies.  The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for PWS. 

ARD-101 is being evaluated in the Phase 3 HERO trial for hyperphagia associated with PWS. 

About ARD-201
ARD-201 is planned to be an oral fixed-dose combination of a dipeptidyl peptidase-4 (DPP-4) inhibitor and the TAS2R agonist ARD-101. These receptors normally respond to nutrients and are part of the gut-brain axis that helps regulate food intake. Activation of TAS2Rs stimulates the release of endogenous signaling molecules, including CCK and GLP-1, which play key roles in promoting satiety and reducing hunger. DPP-4 inhibitors, which are widely used for the treatment of diabetes, extend the biological activity of gut hormones, including GLP-1, by preventing their enzymatic inactivation. Together, these mechanisms allow ARD-201 to enhance and prolong the body’s natural signals for fullness.

Aardvark is advancing ARD-201 in two Phase 2 trials:

• Expected to initiate in the second half of 2025, ARD-201 will be evaluated in the Phase 2 POWER trial for the potential to prevent weight regain in subjects who discontinue GLP-1RA therapy after achieving substantial prior weight loss (~15%).
• Planned for initiation in the first half of 2026, ARD-201 will be evaluated in the Phase 2 STRENGTH trial for potential placebo-adjusted weight loss and the additive effects of ARD-201 combined with GLP-1RA therapy.

About WE-868
WE-868 is a novel, small molecule that modulates mitochondrial energy metabolism without directly suppressing the OXPHOS pathway. It is being evaluated in preclinical studies for the potential treatment of obesity and diabetes.

About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food). Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, and conducting two separate trials with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy; product candidates and programs, including ARD-201, ARD-101 and WE-868; ongoing clinical trials; planned clinical trials; expected timing for data readouts and reporting topline results; likelihood of success; as well as plans and objectives for future operations; ARD-201’s potential, including its potential as a first-in-class therapy and ability to overcome the tolerability and rebound challenges of GLP-1 therapies; and Aardvark’s upcoming webinar and the topics expected to be discussed in such webinar. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical and preclinical trials; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 that the Company filed with the Securities and Exchange Commission on August 13, 2025. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.

Contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
Carolyn.hawley@inizioevoke.com

BrainsWay Reports National Institutes of Health Grant to Leading U.S. Research Team Investigating Accelerated Deep TMS for Treatment of Alcohol Use Disorder




BrainsWay Reports National Institutes of Health Grant to Leading U.S. Research Team Investigating Accelerated Deep TMS for Treatment of Alcohol Use Disorder

New NIH grant awards $2.5 million over 5 years for mechanistic study

BURLINGTON, Mass. and JERUSALEM, Nov. 04, 2025 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the U.S. National Institutes of Health (NIH) has awarded a new grant – totaling approximately $2.5 million over five years – to a research team led by Principal Investigator Dr. Claudia Padula and Co-Investigator Dr. Michelle Madore of Stanford University and the Palo Alto Veterans Institute for Research. The funding will support a clinical study evaluating the mechanism of action and potential efficacy of an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol using BrainsWay’s device to treat Alcohol Use Disorder (AUD).

“This accelerated treatment protocol represents a substantial leap forward in our research on AUD,” said Dr. Colleen Hanlon, Vice President of Medical Affairs BrainsWay. “If we can confirm that this rapid, high-intensity Deep TMS protocol effectively and durably engages the targeted brain circuits and reduces relapse risk, it has the potential to facilitate the development of new, much-needed neuromodulation-based treatment strategies for AUD.”

The study, titled, “Assessing the Impact of dTMS on Neural Targets Associated with Alcohol Use Disorder,” will utilize BrainsWay’s H7 Coil to target brain regions which are associated with core neural mechanisms underlying addiction and relapse risk.

Accelerated, High-Intensity Treatment Protocol

The study features an accelerated dosing schedule, designed to rapidly engage neural targets and improve patient access:

• Protocol: Participants will receive three Deep TMS treatments per day for 10 consecutive business days, totaling 30 treatment sessions.
• Design: The study will enroll 100 adults with AUD in a randomized, double-blind, sham-controlled trial.
• Mechanistic Focus: Researchers will use neuroimaging assessments to investigate the “target engagement” – i.e. neural activation in the targeted brain regions such as the dorsal Anterior Cingulate Cortex (dACC) – in the active group relative to sham. This seeks to link various clinical outcomes being measured in the study (including percentage of days abstinent and heavy drinking days) to any observed brain changes.

This marks the second major NIH grant awarded to this team of researchers in two years, reinforcing their leadership in neuromodulation for addiction. Last year, the same team received a multimillion-dollar NIH grant – with a $1.49M first-year budget – to study a similar accelerated Deep TMS protocol using the H4 Coil for Stimulant Use Disorder (Methamphetamine Use Disorder (MUD)), primarily focusing on veterans.

“We are excited to see clinical studies evaluating the use of accelerated Deep TMS being conducted by such highly distinguished researchers,” stated Hadar Levy, Chief Executive Officer of BrainsWay. “If successful, the findings from the MUD and AUD studies may lead to significantly expanded adoption of advanced, noninvasive neuromodulation techniques to treat substance use disorders.”

This new research follows other recent Company developments relating to the use of accelerated protocols with its products. BrainsWay recently announced that it received FDA clearance for its H1 Coil for the accelerated treatment of patients suffering from major depressive disorder (MDD), including those with comorbid anxiety symptoms.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.

Forward-Looking Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “targets,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies – especially preliminary data which remains subject to peer-review – do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

Boehringer Ingelheim and CDR-Life Expand Collaboration Efforts with Global Licensing Agreement for CDR111, an Antibody-Based Trispecific M-gager® for Autoimmune Diseases




Boehringer Ingelheim and CDR-Life Expand Collaboration Efforts with Global Licensing Agreement for CDR111, an Antibody-Based Trispecific M-gager® for Autoimmune Diseases

• New deal builds on the success of a longstanding partnership in retinal health and the potential of CDR-Life’s unique antibody fragment-based platform  
   
• Agreement provides potential for up to approx. USD 570 million in total payments including approx. USD 48 million in upfront and near-term payments, plus tiered royalties 

Ingelheim, Germany and Zurich, Switzerland – November 4, 2025 – Boehringer Ingelheim and CDR-Life, Inc. today announced a new global licensing agreement to develop CDR-Life’s unique antibody based  molecule  CDR111 for autoimmune diseases. CDR111 is a trispecific M-gager®, an antibody-based T-cell engager designed to selectively target and deplete B cells, with the goal of achieving immune system reset. 

Dysregulated B cells play a central role in driving many autoimmune and inflammatory conditions such as lupus, multiple sclerosis and certain forms of arthritis. Therefore, an approach that can deeply deplete these cells could have broad and far-reaching potential across multiple indications. 

The agreement builds on the companies’ successful collaboration on an investigational antibody fragment. Boehringer has developed this molecule with technology licensed from CDR-Life, with the goal of preserving vision in people living with geographic atrophy (GA). It is currently being investigated in the VERDANT™ Phase 2 trial (NCT06722157).  

“Our expanded collaboration with Boehringer underscores the growing recognition of our platform’s ability to design high quality biologics that may translate into meaningful therapeutic advances,” said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. “Having already demonstrated encouraging clinical progress together in GA, this new agreement further validates the versatility of our T-cell engager technology, and we are excited to see Boehringer advance CDR111 toward the clinic.” 

“We are excited to expand upon our work with CDR-Life and apply their trispecific M-gager approach to autoimmune and inflammatory diseases with high unmet need, further broadening our differentiated pipeline,” said Carine Boustany, US Innovation Unit Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. “We see strong potential for CDR111 to demonstrate a deep and durable immune reset that may deliver transformative options for patients living with serious autoimmune disease.”  

Under the terms of the agreement, CDR-Life is eligible for up to a total of CHF 456 million (approximately USD 570 million) in payments including CHF 38 million (approximately USD 48 million) in upfront and near-term payments, plus tiered royalties on future sales. 

About Boehringer Ingelheim 

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-Ingelheim.com.  

About CDR-Life 

CDR-Life develops highly targeted T cell engagers (TCEs) for the treatment of solid cancers and autoimmune diseases. Our M-gager® platform delivers TCEs against challenging but clean targets through unparalleled binding-specificity. With our first oncology program now in clinical trials, we are advancing a pipeline of potent and selective TCE therapeutics. Our longstanding partnership with Boehringer Ingelheim on a molecule derived from our M-gager® platform, now in Phase 2, demonstrates the potential of our antibody-derived molecules. Backed by leading cross-Atlantic investors, our team is committed to bringing life-changing, disease-modifying medicines to patients globally. Learn more at www.cdr-life.com. 

Boehringer Ingelheim Contact: 

Dr. Reinhard Malin 
Boehringer Ingelheim Corporate Center GmbH  
Innovation Unit/Bio Comms, Corp. Affairs  
Media + PR  
press@boehringer-ingelheim.com  

CDR-Life Contacts: 

Media: 
Lauren Arnold 
LA Communications 
Lauren@lacommunications.net 

Investors: 

Christian Leisner, CEO
CDR-Life Inc.
Christian.leisner@cdr-life.com 

Ardelyx President and Chief Executive Officer Mike Raab to Participate in the Wedbush Rewind American Society of Nephrology 2025 Investor Conference




Ardelyx President and Chief Executive Officer Mike Raab to Participate in the Wedbush Rewind American Society of Nephrology 2025 Investor Conference

WALTHAM, Mass., Nov. 04, 2025 (GLOBE NEWSWIRE) — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that President and CEO, Mike Raab will participate in a fireside chat at the Wedbush Rewind ASN 2025 Conference on Monday, November 10, 2025 from 11:30 a.m. to 12:00 p.m. ET.

To access the public webcast of the event, please visit the Events and Presentations page within the Ardelyx website at https://ardelyx.com/. A replay of the event will be available on the Ardelyx website for 30 days following the event.

About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) as well as early-stage pipeline candidates. The company is developing RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas. Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.

Investor and Media Contacts:
Caitlin Lowie
clowie@ardelyx.com

Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE® (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology




Arcutis Announces Publication of Positive Long-Term Safety and Efficacy Data of ZORYVE® (roflumilast) Foam 0.3% in Individuals with Seborrheic Dermatitis in American Journal of Clinical Dermatology

• ZORYVE foam 0.3% was safe, well-tolerated, and demonstrated durable and continuously improving efficacy in the treatment of seborrheic dermatitis up to 52 weeks
• Once-daily ZORYVE foam 0.3% is approved to treat seborrheic dermatitis in adults and adolescents 9 years of age and older

WESTLAKE VILLAGE, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, today announced that the American Journal of Clinical Dermatology published data from the Phase 2 long-term safety open-label extension (OLE) study that demonstrated once-daily ZORYVE^® (roflumilast) foam 0.3% is safe, well-tolerated, and efficacious for up to 52 weeks of treatment in individuals with seborrheic dermatitis. ZORYVE foam was approved in December 2023 by the U.S. Food & Drug Administration (FDA) for the topical treatment of seborrheic dermatitis in adults and adolescents 9 years of age and older; in 2025 it was also approved for the topical treatment of scalp and body plaque psoriasis in adults and adolescents 12 years of age and older and is available in pharmacies nationwide.   

“In my practice, I often see individuals with seborrheic dermatitis struggling with persistent itching, redness, and scaling in visible areas like the scalp, face, and chest. For many, this chronic condition is not only uncomfortable but also affects their self-esteem and quality of life,” said Andrew Alexis, MD, MPH, New York-based dermatologist and lead author of the paper. “While topical antifungals, topical corticosteroids, and medicated shampoos are often used, these treatment routines can be complex and often fall short of desired patient outcomes. ZORYVE foam represents a meaningful advancement for individuals living with this burdensome disease.”

This Phase 2, open-label safety trial was conducted in individuals aged ≥12 years with moderate to severe seborrheic dermatitis who had previously been treated with ZORYVE foam in a separate Phase 2 double-blind study or were treatment-naive. During the study, all participants (n=400) applied ZORYVE foam once daily, as a monotherapy treatment, to all areas of their bodies impacted by seborrheic dermatitis, including on the scalp, face, trunk, and intertriginous areas. Once patients’ disease had cleared (IGA=0) they were able to stop treatment and restart with any sign of disease returning. Of the 400 participants, 338 participants were enrolled for 24 weeks and 62 participants were enrolled to continue through 52 weeks.

The primary endpoint was safety. Treatment-Emergent Adverse Events (TEAEs) were reported for 130 (32.5%) participants. The most common TEAE (≥2%) was COVID-19, which was reported for 15 (3.8%) participants, followed by headache in 13 (3.3%) participants. Serious Adverse Events (SAEs) were reported for 7 (1.8%) individuals, none of which were considered treatment related. Overall, 5 of 400 participants (1.3%) discontinued the trial because of an AE.

Based on investigator-rated local tolerability assessments, ≥96% of study participants had no evidence of local irritation. For patient-reported local tolerability assessments, ≤1.1% of participants reported a stinging sensation at the application site. Additionally, most participants with hyperpigmentation or hypopigmentation at baseline experienced full resolution by the end of the study.

As previously reported, durable and continuously improving efficacy was observed in the study. In individuals who completed 52 weeks of treatment with ZORYVE foam (n=46), 24 (52.2%) achieved an Investigator Global Assessment (IGA) of Clear (0) at Week 52. On the assessment of IGA of Clear or Almost Clear (0 or 1), 56.4% (219/388) attained this level of efficacy at Week 4, 76% (260/342) at Week 24, and 80.4% (37/46) at Week 52. Moreover, ZORYVE foam treatment resulted in high proportions of participants with no erythema (redness) and scaling throughout the trial.

Treatment with ZORYVE foam resulted in sustained improvement in itch, as measured by the Worst Itch Numeric Rating Scale (WI-NRS), with 71.3% (189/265) of participants with WI-NRS ≥4 at baseline achieving a clinically significant response (≥4-point improvement) at Week 24 and 58.1% at Week 52 (18/31).

“Seborrheic dermatitis is a common, chronic inflammatory skin disease and data on its pathophysiology published over the last year demonstrate it has a distinct immunological and molecular profile, including a unique skin barrier disruption. ZORYVE foam is the first topical with a new mechanism of action approved for seborrheic dermatitis in 20 years,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer, Arcutis Biotherapeutics. “The publication of these data reinforces the strong efficacy and safety of once-daily ZORYVE foam and underscores our dedication to providing dermatologists and individuals living with chronic inflammatory skin conditions with treatment options that can be used with confidence over the long term.”

About ZORYVE® (roflumilast)
ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined—atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.

ZORYVE was awarded by Allure with a prestigious “2025 Best of Beauty Breakthrough Award,” making it the first FDA-approved medication for atopic dermatitis, plaque psoriasis, and seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. ZORYVE cream 0.15% is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for “Eczema Product.” Additionally, the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adult patients with mild to moderate atopic dermatitis, according to updated guidelines released June 26, 2025. ZORYVE topical foam 0.3% is approved by the FDA for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. Both ZORYVE cream 0.3% and ZORYVE foam 0.3% were awarded the National Psoriasis Foundation’s Seal of Recognition—the first FDA-approved product to receive the honor.

INDICATIONS 
ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age. 

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. 

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.   

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. 

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.   

IMPORTANT SAFETY INFORMATION   
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).  

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. 

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%). 

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). 

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).  

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). 

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). 

Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.   

About Arcutis 
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. 

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the long-term use of ZORYVE in seborrheic dermatitis patients. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. 

Contacts
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com 

National Committee for Quality Assurance (NCQA) Renews Healthmap Solutions’ Population Health Program Accreditation




National Committee for Quality Assurance (NCQA) Renews Healthmap Solutions’ Population Health Program Accreditation

TAMPA, Fla., Nov. 04, 2025 (GLOBE NEWSWIRE) — Healthmap Solutions, Inc. (Healthmap) announced today that it has earned a three-year renewal of its NCQA Population Health Program Accreditation for its Kidney Population Health Management program.

Healthmap Chief Medical Officer Howard Shaps, MD, MBA said, “This accreditation renewal validates our team’s ongoing dedication to clinical quality and patient-centered population health management. We remain focused on improving quality of care for members in our program, and we are thrilled to be recognized by NCQA for these efforts.”

NCQA Accreditation standards are developed with input from various stakeholders and resources, including health plans, population health management industry leaders, an expert panel, and standing committees. These standards are purposely set high to encourage organizations to continuously enhance their quality. The NCQA Population Health Program Accreditation involves an assessment of several standards, including data integration, population assessment, population segmentation, targeted interventions, practitioner support, measurement, and quality improvement.

Healthmap CEO Eric Reimer said, “Quality is at the center of our Kidney Population Health Management program, and this accreditation is truly a company-wide achievement. Every member of the Healthmap team is committed to ensuring the highest standards of quality every day. I’m especially thankful for our front-line team members who work directly with patients, providers, and clients to make sure we consistently deliver meaningful value while meeting NCQA’s rigorous standards.”

Healthmap’s Kidney Population Health Management program uses advanced data analytics and clinical expertise to improve care and lower costs for patients with kidney disease. Healthmap delivers actionable, clinically proven insights and patient-centered care recommendations to healthcare providers while connecting with patients to provide the support and information they need to adhere to their treatment plan.

About NCQA
NCQA is a private, nonprofit organization dedicated to improving health care quality. NCQA Accredits and Certifies a wide range of health care organizations. It also Recognizes clinicians and practices in key areas of performance. NCQA’s Healthcare Effectiveness Data and Information Set (HEDIS^®) is the most widely used performance measurement tool in health care. NCQA’s website (ncqa.org) contains information to help consumers, employers and others make informed health care choices. NCQA can also be found at Twitter/X@ncqa and on LinkedIn at linkedin.com/company/ncqa.

About Healthmap Solutions
Healthmap Solutions (Healthmap) is a leading Kidney Population Health Management company serving health plans, health systems, accountable care organizations (ACOs), and provider groups seeking value-based solutions that improve the clinical care and financial performance of high-risk, high-cost kidney patient populations.

Media contact:
Chris Cooney
President
The WilMark Group
(407) 921-6932
chris@wilmarkgroup.com

Zelluna ASA: Disclosure of large shareholding




Zelluna ASA: Disclosure of large shareholding

In accordance with the Norwegian Securities Trading Act Section 4-3, Inven2 AS ( “Inven2” ) hereby notifies that its ownership interest in Zelluna ASA (“Zelluna”) has fallen below the 10% threshold following the share capital increase in Zelluna through the private placement on November 3^rd 2025.

Previous shareholding : 10,79%

New shareholding : 9,01%

Total number of shares held: 2,207,034

The reduction in ownership is due to dilution as result of the private placement. Inven2 has not sold any shares.

This notification is submitted pursuant to section 4-3 of the Norwegian Securities Trading Act and the Osl rule Book II – Issuer Rules.

Ascentage Pharma to Present Data from Multiple Studies of Olverembatinib, Including the First Dataset from POLARIS-1 Study, at ASH 2025




Ascentage Pharma to Present Data from Multiple Studies of Olverembatinib, Including the First Dataset from POLARIS-1 Study, at ASH 2025

ROCKVILLE, Md. and SUZHOU, China, Nov. 03, 2025 (GLOBE NEWSWIRE) — Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that the latest results from multiple clinical studies of its novel drug, olverembatinib (HQP1351), have been selected for presentations at the 67th American Society of Hematology (ASH) Annual Meeting, marking the eighth consecutive year in which clinical data on olverembatinib have been selected by ASH for the Annual Meeting. This year, multiple clinical and preclinical studies on three of the company’s investigational drug candidates (olverembatinib, lisaftoclax and APG-5918) have been selected for presentations at the ASH Annual Meeting.

Developed by Ascentage Pharma, olverembatinib is the first China-approved third-generation BCR-ABL inhibitor, currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. At this year’s ASH Annual Meeting, Ascentage Pharma will release the first dataset from the global Phase III study (POLARIS-1) of olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Moreover, 4-year follow-up data from a randomized controlled, registrational Phase II study of olverembatinib in patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP); and updated data on olverembatinib in the second-line treatment of patients with non-T315I-mutant CML-CP are also set to be reported at the ASH Annual Meeting.

The ASH Annual Meeting is one of the largest gatherings of the international hematology community, aggregating the latest scientific research on the pathogenesis and clinical treatment of hematologic diseases. The 67th ASH Annual Meeting will take place on December 6-9, 2025, local time, both online and in-person in Orlando, Florida.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, “For eight years in a row, clinical data on olverembatinib have been selected by the ASH Annual Meeting, an achievement reflecting the strong recognition of olverembatinib by the international hematology community. Olverembatinib is currently being evaluated in three global registrational Phase III studies. This year, multiple studies of our three key drug candidates have been selected for presentation at the ASH annual Meeting, underscoring Ascentage Pharma’s robust capabilities in global innovation and clinical development. We look forward to sharing more detailed data during the conference. Moving forward, we will continue to accelerate our clinical development programs in efforts to bring more treatment options to patients as soon as possible.”

An overview of presentations featuring Ascentage Pharma’s drug candidates at ASH 2025:

Major study abstracts on olverembatinib selected for presentations at the 2025 ASH Annual Meeting are as follows: (for details on the abstracts featuring lisaftoclax, please refer to a separate press release published at the same time)

Results of POLARIS-1, a global Phase 3 study (Part A): olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)
Format: Poster Presentation
Abstract#: 1574
Session: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Poster I
Time: Saturday, December 6, 2025; 5:30 PM – 7:30 PM EST
First Author: Prof. Suning Chen, Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China
Presenter: Prof. Suning Chen, Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China
Highlights:
This is a global registrational Phase III study (POLARIS-1; NCT06051409) designed to evaluate the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in patients with ND Ph⁺ ALL. The primary endpoint of the study was minimal residual disease (MRD; BCR-ABL/ABL1 ≤ 0.01% by qPCR) negativity rate by the end of three induction cycles.

Efficacy Results:

• As of July 18, 2025, among 53 efficacy‑evaluable patients, 50 (94.3%) achieved a complete remission (CR) or CR with incomplete hematologic recovery by the end of induction therapy. The best MRD negativity and MRD-negative CR rates were 66.0% and 64.2%, respectively.
• IKZF1^plus (particularly with concurrent BTG1 deletion) is a widely recognized high-risk factor in B-ALL as it can often cause resistance to chemotherapies and a high propensity to relapse. Among the 10 patients in this study who had this genotype, the molecular response rate at the end of the induction therapy was 90% (9/10).

Safety Results: Olverembatinib in combination with low-dose chemotherapy was well tolerated. Common (incidence >15%) grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (63.6%), thrombocytopenia (56.4%), leukopenia (54.5%), anemia (49.1%), pneumonia (30.9%), hypokalemia (20%), and abnormal hepatic function (16.4%).

Conclusion:
In patients with ND Ph⁺ ALL, olverembatinib in combination with chemotherapy demonstrated an MRD-negative CR rate of 64.2% by the end of the induction therapy and a favorable safety profile.

Olverembatinib (HQP1351) demonstrates efficacy vs. best available therapy (BAT) in patients (pts) with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) in a registrational randomized phase 2 trial: up to 4-year follow-up including patients without T315I mutations
Format: Poster Presentation
Abstract#: 3788
Session:  632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II
Time: Sunday, December 7, 2025; 06:00 PM – 08:00 PM EST
First Author: Prof. Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital, Beijing, China
Presenter: Prof. Qian Jiang, Peking University Institute of Hematology, Peking University People’s Hospital, Beijing, China
Highlights:

• This is an open-label, randomized controlled, multicenter, pivotal registrational phase II study (NCT04126681) designed to evaluate the efficacy and safety of olverembatinib in patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs. This report features an update on the results released in an oral presentation at ASH 2023. As of January 13, 2025, a total of 144 patients with CML-CP were enrolled in the study, including 105 patients without the T315I mutation.
• In this study, patients were randomized at a 2:1 ratio to the olverembatinib arm or the control arm with investigators’ choices of best available treatment (BAT). The primary endpoint is event-free survival (EFS).

Efficacy Results:

• The olverembatinib arm achieved a significantly longer EFS than the BAT arm: among all patients with CML-CP, the median EFS of the olverembatinib arm and the BAT arm were 21.22 months and 2.86 months (P < 0.001), respectively. Among patients with CML-CP without the T315I mutation, the median EFS of the olverembatinib arm and the BAT arm were 11.96 months and 3.14 months (P = 0.0159), respectively.
• Other efficacy parameters of the olverembatinib arm were significantly better than those of the BAT arm: among all patients with CML-CP, complete hematologic response (CHR) rates of the olverembatinib arm and the BAT arm were 85% and 34.8%; the complete cytogenetic response (CCyR) rates were 37.5% and 18.9%; the major molecular response (MMR) rates were 29.5% and 8.1%, respectively. Among patients with CML-CP without the T315I mutation treated in the olverembatinib arm or the BAT arm, the CHR rates were 82.1% and 50.0%, the CCyR rates were 25.8% and 20.7%, the MMR rates were 16.1% and 10.3%, respectively.

Safety Results: Both olverembatinib and BAT showed a favorable safety profile in patients with CML-CP with/without the T315I mutation. Major adverse event were hematologic toxicities.

Conclusion: Olverembatinib demonstrated clear therapeutic advantage over the BAT arm in patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs.

Updated efficacy and safety of olverembatinib (HQP1351) as second-line therapy in patients with chronic phase-chronic myeloid leukemia (CP-CML)
Format: Poster Presentation
Abstract#: 3782
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II
Time: Sunday, December 7, 2025; 6:00 PM – 8:00 PM EST
First Author: Prof. Weiming Li, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Presenter: Prof. Weiming Li, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Highlights:
This is an open-label, single-arm, multicenter clinical study (ChiCTR2200061655) designed to evaluate the efficacy and safety of orally administered olverembatinib at 40 mg every other day (QOD) in patients with CP-CML resistant/intolerant to one prior line of TKIs (including imatinib, flumatinib, nilotinib, and dasatinib) without the T315I mutation. As of July 24, 2025, the study has enrolled a total of 47 patients with CP-CML without the T315I mutation.

Efficacy Results:

• As of July 24, 2025, 39 (83.0%) patients received at least one efficacy evaluation; 36 (76.6%) at least two efficacy evaluations; and 34 (72.3%) at least three efficacy evaluations. Two patients had not yet received their first efficacy evaluation.
• As of the data cut-off date, 71.8% (28/39) of patients achieved a CCyR and 43.6% (17/39) MMR. CCyR and MMR rates assessed at the end of cycles 6, 9, 12, 15, 18, 21, and 24 were 54.3% and 25.7%, 66.7% and 33.3%, 74.2% and 35.5%, 84.6% and 46.2%, 85.7% and 47.6%, 90.0% and 60.0%, and 89.5% and 57.9%, respectively, suggesting that responses deepened as treatment persisted.
• Among 39 efficacy-evaluable patients, 30 had received second-generation TKIs in first-line treatment. Of them, 76.7% (23/30) achieved a CCyR and 43.3% (13/30) MMR. Among the 9 patients who were pretreated with imatinib, 55.6% (5/9) achieved a CCyR and 44.4% (4/9) MMR.

Safety Results: The median (range) treatment duration was 16.0 (1-18) cycles. A total of 42 (89.4%) patients experienced treatment-related adverse events (TRAEs) of any grade, including 21 (44.7%) patients who experienced grade ≥3 TRAEs and 6 (12.8%) patients who experienced serious adverse events (SAEs) related to olverembatinib. Grade ≥3 hematologic toxicities included platelet count decreased (42.6%), neutropenia (25.5%), and anemia (8.5%). Olverembatinib-related SAEs included platelet count decreased (6.4%) and anemia, myelosuppression, and pyrexia (2.1% each). No deaths were reported during the study.

Conclusion: Olverembatinib may provide a safe and effective second-line treatment for patients with CP-CML, especially for those with disease that had failed on first-line treatment with second-generation TKIs.

* Olverembatinib, lisaftoclax and APG-5918 are currently under investigation and have not yet been approved by the FDA in the US.

About Ascentage Pharma

Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors.

The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting an FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients.

The Company’s second approved product, Lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA-cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia ( AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the US FDA, the EMA of the EU, and China CDE.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition.

These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.

As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts
Investor Relations:
Hogan Wan, Head of IR and Strategy
Ascentage Pharma
Hogan.Wan@ascentage.com
+86 512 85557777

Stephanie Carrington
ICR Healthcare
AscentageIR@icrhealthcare.com
+1 (646) 277-1282

Media Relations:
Jon Yu
ICR Healthcare
AscentagePR@icrhealthcare.com
+1 (646) 677-1855