Merck Provides New Results for VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction




Merck Provides New Results for VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction

Results from the Phase 3 VICTOR trial and a pooled analysis of the VICTOR and VICTORIA trials were presented today at the ESC Congress 2025 and simultaneously published in The Lancet

RAHWAY, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results evaluating VERQUVO^® (vericiguat) in adult patients with stable chronic heart failure and reduced ejection fraction (HFrEF). The Phase 3 VICTOR trial comparing the efficacy of VERQUVO to placebo in patients with HFrEF without a recent worsening heart failure event treated with guideline-directed medical therapy (GDMT) did not reach statistical significance for its primary endpoint of combined time to first event of cardiovascular death or hospitalization for heart failure. In a separate pre-specified pooled analysis of patient-level data from the complementary Phase 3 VICTOR and VICTORIA trials, VERQUVO reduced the risk of the composite primary endpoint of cardiovascular death or heart failure hospitalization across these patients with a broad range of disease severity. Results from both analyses were presented today at the European Society of Cardiology (ESC) Congress 2025 in a Hot Line session and simultaneously published in The Lancet.

VERQUVO was initially studied and approved in patients with worsening chronic heart failure and ejection fraction less than 45% following a worsening heart failure event based on the pivotal Phase 3 VICTORIA trial. Participants in the VICTOR trial represented a well-treated group of ambulatory HFrEF patients on GDMT and 47.5% of participants had no history of hospitalization for heart failure. Results showed that VERQUVO did not significantly reduce the risk of the primary composite outcome of time to cardiovascular death or hospitalization for heart failure, which occurred in 18% (n=549/3,053) of patients treated with VERQUVO compared to 19.1% (n=584/3,052) in the placebo group (hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.83-1.04; p=0.22). For the key secondary endpoints, cardiovascular death was numerically lower with VERQUVO (9.6%) compared to placebo (11.3%) (HR 0.83; 95% CI 0.71-0.97) and heart failure hospitalization occurred in 11.4% of patients receiving VERQUVO and 11.9% of patients receiving placebo (HR 0.95; 95% CI 0.82–1.10). The overall safety profile of VERQUVO in the VICTOR trial was consistent with previous clinical trials.

“By studying patients without recent heart failure hospitalizations, the Phase 3 VICTOR trial expands our understanding of VERQUVO across the full spectrum of chronic heart failure patients with reduced ejection fraction,” said Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories. “Together with the previously communicated results in VICTORIA in patients with worsening chronic heart failure and ejection fraction less than 45% following a worsening heart failure event, the results today provide valuable information and add to our understanding of heart failure and VERQUVO. We are grateful to the patients and investigators for their participation in these studies and remain confident in the role of VERQUVO for its approved indication for patients with HFrEF following a recent heart failure event and with ejection fraction less than 45% based on the pivotal Phase 3 VICTORIA trial.”

The Phase 3 VICTORIA trial focused exclusively on a population with worsening chronic HFrEF at high risk for cardiovascular mortality and repeated heart failure hospitalizations. In a separate pre-specified pooled analysis across VICTOR and VICTORIA, VERQUVO’s benefit was examined in a large and broad cohort. In this pooled analysis of 11,155 HFrEF patients, VERQUVO showed a statistically significant risk reduction across the primary composite endpoint of cardiovascular death or heart failure hospitalization and its components as secondary endpoints, in a broad spectrum of patients with HFrEF. No new safety signals, beyond those reported in the individual trials, emerged in the pooled analysis.

“While the VICTOR trial did not meet its primary endpoint, the separate pooled analysis across both VICTOR and VICTORIA did demonstrate a statistically significant reduction in the primary composite endpoint of heart failure hospitalization and cardiovascular deaths in patients with heart failure and reduced ejection fraction across the disease severity,” said Javed Butler, MD, MPH, MBA, President of the Baylor Scott and White Research Institute and Professor of Medicine at University of Mississippi in Jackson, Mississippi.

The positive benefit-risk profile of VERQUVO in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase 3 VICTORIA trial remains unchanged. In the U.S., VERQUVO is approved for the reduction of risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

About VICTOR

VICTOR (VerICiguaT in adults with ChrOnic heart failure and Reduced ejection fraction) (NCT05093933) was a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase 3 study investigating the efficacy and safety of VERQUVO in adult patients with symptomatic chronic heart failure (New York Heart Association [NYHA] class II-IV) and a left ventricular ejection fraction (LVEF) of 40% or less. It enrolled 6,105 patients with chronic heart failure with reduced ejection fraction (HFrEF), who had not had a recent hospitalization for heart failure within 6 months or the need for outpatient intravenous diuretics within 3 months before randomization. Patients receiving contemporary guideline-directed medical therapy (GDMT), including SGLT2-inhibitors and angiotensin receptor-neprilysin inhibitor (ARNI), were randomized to receive either VERQUVO or placebo. VICTOR was the first large event-driven HFrEF trial performed in the contemporary era of quadruple foundational GDMT, in a compensated ambulatory heart failure population. Merck and Bayer AG are co-developers of the VICTOR trial. The study was executed by Merck.

About VICTORIA

VICTORIA (NCT02861534) was a randomized, placebo-controlled, parallel-group, multi-center, double-blind, Phase 3 study of VERQUVO versus placebo when given in combination with available heart failure therapies in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) following a decompensation event, defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization. The primary endpoint of the study was the composite of time to first occurrence of cardiovascular death or heart failure hospitalization. Secondary endpoints included time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalization, time to total heart failure hospitalizations (including first and recurrent events), time to the composite of all-cause mortality or heart failure hospitalization, and time to all-cause mortality. The study enrolled 5,050 patients who were randomized to receive either VERQUVO once daily (titrated up to 10 mg) or placebo when given in combination with available heart failure therapies. The study, which was co-sponsored by Merck and Bayer, was conducted in collaboration with the Canadian VIGOUR Centre and the Duke Clinical Research Institute in more than 600 centers in 42 countries.

About VERQUVO (vericiguat)

VERQUVO is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, VERQUVO augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

VERQUVO is FDA-approved to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Selected Safety Information for VERQUVO (vericiguat) tablets (2.5 mg, 5 mg, and 10 mg)

WARNING: EMBRYO-FETAL TOXICITY

Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.

VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. VERQUVO is contraindicated in pregnancy. Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.

In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency greater than or equal to 5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).

Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension.

There are no data on the presence of VERQUVO in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.

About Heart Failure with Reduced Ejection Fraction

Heart failure with reduced ejection fraction (HFrEF), formerly known as systolic heart failure, is characterized by the compromised ability of the heart to pump blood sufficiently during its contraction phase. In the U.S., approximately 6.2 million adults (20 years of age and older) have heart failure, and approximately 50% of heart failure patients have HFrEF. An observational, cohort analysis of PINNACLE registry data showed that approximately half of patients with worsening chronic HFrEF are rehospitalized within 30 days of a worsening event, and an estimated one in five patients with worsening chronic HFrEF will die within two years.

About the Worldwide Collaboration between Merck and Bayer

Since October 2014, Bayer and Merck (known as MSD outside the U.S. and Canada) have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and MSD. MSD has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), LinkedIn and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_pi.pdf and Medication Guide at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_mg.pdf.

Contacts

Media Contacts:

Julie Cunningham, (617) 519-6264

Elizabeth Sell, (484) 689-9978

Investor Contacts:

Peter Dannenbaum, (732) 594-1579

Ayn Wisler, (917) 691-6218

Exelixis Announces Appointment of Dana T. Aftab, Ph.D. as Executive Vice President, Research and Development




Exelixis Announces Appointment of Dana T. Aftab, Ph.D. as Executive Vice President, Research and Development

– Dr. Aftab has served for over 25 years at Exelixis and has been instrumental in driving the company’s scientific innovation and development activities –

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced it has appointed Dana T. Aftab, Ph.D., as its Executive Vice President, Research and Development. In this new role, Dr. Aftab will oversee all aspects of the company’s drug discovery, translational research, product development and medical affairs activities.

“Dana has been an integral part of the Exelixis team for more than 25 years, with deep expertise that spans the drug discovery and development continuum. He’s been a key contributor to many of Exelixis’ most important milestones, including the discovery, development and introduction of cabozantinib, which he and the broader Exelixis team grew from an initial orphan drug indication into a global oncology franchise,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. “Dana is an excellent choice to lead Exelixis’ wide-ranging product development organization as the team maximizes the opportunities for our portfolio, which in addition to cabozantinib includes zanzalintinib, our third-generation oral tyrosine kinase inhibitor that is the subject of multiple pivotal trials, as well as our earlier stage pipeline of promising small molecules and biotherapeutics.”

Dr. Aftab joined Exelixis in 1998, and since then has played a key role in the discovery and development of the company’s flagship medicine, CABOMETYX® (cabozantinib), which is currently the leading tyrosine kinase inhibitor in the U.S. for both the treatment of advanced renal cell carcinoma and advanced neuroendocrine tumors. During his tenure at Exelixis, Dr. Aftab held diverse roles across the company’s research and development organizations, and most recently served as Executive Vice President, Discovery and Translational Research and Chief Scientific Officer since December 2022. In that role he has overseen the development of the company’s early pipeline, as well as of the translational medicine and clinical pharmacology teams supporting work streams across the spectrum of discovery research and product development. Dr. Aftab holds a Ph.D. degree in pharmacology from Yale University and conducted postdoctoral work at the University of California, Berkeley in the field of oncogene signaling.

Amy Peterson, M.D., who served as Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer since August 2023 has departed Exelixis.

About Exelixis

Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules and biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX^® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to Exelixis’ senior officer transitions. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation, factors affecting Exelixis discussed under the caption “Risk Factors” in Exelixis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 11, 2025, and in Exelixis’ subsequent filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks.

Contacts

Investors Contact:
Susan Hubbard
EVP, Public Affairs and
Investor Relations
Exelixis, Inc.
(650) 837-8194
shubbard@exelixis.com

Media Contact:
Hal Mackins
For Exelixis, Inc.
(415) 994-0040
hal@torchcommunications.com

GenSight Biologics Postpones Release of 2025 Half-Year Financial Results




GenSight Biologics Postpones Release of 2025 Half-Year Financial Results

PARIS–(BUSINESS WIRE)–Regulatory News:

GenSight Biologics (“GenSight Biologics” or the “Company“) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the release of its half-year financial results, originally scheduled for September 19, 2025, has been postponed to September 29, 2025, after the market closes.

The postponement allows the Company’s external auditors to complete all necessary audit procedures to the highest professional standards. The Company confirms that the postponement relates only to the time required for the audit rather than to any material issues with the financial statements. The extension permits full compliance with regulatory requirements and maintains the Company’s commitment to accurate and transparent financial reporting.

The Company’s Audit Committee and Board of Directors meetings have been rescheduled accordingly:

• Audit Committee: postponed to September 24, 2025
• Board Meeting: postponed to September 26, 2025

The half-year results will be made available in the investor relations section of the Company’s website immediately following the September 29 announcement.

About GenSight Biologics S.A.

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010 (lenadogene nolparvovec)/GS010 is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. The product candidate GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially.

Contacts

GenSight Biologics
Chief Financial Officer

Jan Eryk Umiastowski

jeumiastowski@gensight-biologics.com

Binge Eating Disorders Global Market Research Report 2025-2035 | Growth Influenced by Rising Prevalence, Improved Diagnosis, Mental Health Awareness, and Advances in Patient-Centric Treatments – ResearchAndMarkets.com




Binge Eating Disorders Global Market Research Report 2025-2035 | Growth Influenced by Rising Prevalence, Improved Diagnosis, Mental Health Awareness, and Advances in Patient-Centric Treatments – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Binge Eating Disorders Market – A Global and Regional Analysis: Focus on Drug Class and Region – Analysis and Forecast, 2025-2035” report has been added to ResearchAndMarkets.com’s offering.

BED is characterized by recurrent episodes of excessive food consumption accompanied by feelings of loss of control and distress, impacting both psychological and physical health. Notably, advances in screening tools, behavioural therapies, and pharmacological treatments are enabling earlier and more accurate diagnosis, boosting demand for personalized intervention strategies.

However, challenges such as social stigma, limited access to specialized care in low-resource settings, and reimbursement barriers continue to restrict market penetration. Additionally, the heterogeneous nature of BED symptoms and the requirement for integrated, long-term care complicate treatment standardization and scalability. Nevertheless, increasing government initiatives, growing investment in mental health research, and expanded patient support programs are fostering new growth opportunities. Collaborative efforts among healthcare providers, researchers, and advocacy organizations are advancing clinical outcomes and improving quality of life for individuals affected by BED.

Impact

Technological advancements in digital health, teletherapy, and data analytics are significantly improving the diagnosis and management of binge eating disorders (BED). Innovations such as AI-powered screening tools and mobile health applications enable more accurate identification of symptoms and personalized treatment plans. The rise of digital therapeutics and remote counselling platforms is expanding access to behavioural interventions, especially in underserved or remote regions.

Anticonvulsant medications hold the largest market share. This dominance is attributed to robust clinical evidence supporting their efficacy in reducing binge episode frequency and severity. Topiramate has demonstrated significant effectiveness in clinical trials, leading to its widespread adoption in treating moderate to severe BED.

North America holds the highest market share in the binge eating disorders (BED) market, primarily driven by increased awareness, better diagnostic facilities, and higher healthcare expenditure in the region. The U.S. has a well-established healthcare infrastructure and strong government initiatives focused on mental health, facilitating early diagnosis and treatment of BED. Additionally, the presence of major pharmaceutical companies actively investing in research and development for novel BED therapies further consolidates North America’s leading position.

How can this report add value to an organization?

Product/Innovation: This report provides comprehensive insights into the current trends in binge eating disorders, helping companies identify opportunities for drug and technology development. Organizations can leverage these insights to design therapies, medications, and platforms tailored to the needs of patients suffering from binge eating disorders, improving outcomes and enhancing market penetration.

Competitive: A detailed competitive landscape analysis helps organizations benchmark their market standing against key players. By understanding the strengths and weaknesses of competitors, companies can position themselves more effectively in the global binge eating disorders market.

Demand Drivers and Limitations

Demand Drivers for the Global Binge Eating Disorders Market:

• The growing prevalence and diagnosis of binge eating disorder globally and expanding the patient pool. This increased detection fuels demand for effective treatments.
• Enhanced mental health awareness and reduced stigma encourage more individuals to seek professional help. Greater acceptance supports higher treatment adoption rates.
• Advancements in treatment options and patient centric care models improve outcomes. Personalized approaches are attracting more patients to engage in care.

Limitations for the Global Binge Eating Disorders Market:

• Underdiagnosis remains a significant issue due to social stigma and limited public awareness. This results in many patients not receiving timely or appropriate treatment.
• The high cost of innovative therapies restricts access for a large portion of the patient population. Affordability remains a barrier, especially in lower-income regions.
• Regulatory hurdles contribute to prolonged approval timelines for new drugs. These delays slow down the availability of advanced treatment options in the market.

Key Market Players and Competition Synopsis

The companies profiled in this report have been selected based on their market presence, product portfolio, and competitive positioning in the global binge eating disorders market

• Eli Lilly and Company
• Amneal Pharmaceuticals, Inc.
• Takeda Pharmaceutical, Ltd.
• Tryp Therapeutics Inc.
• Tonix Pharmaceuticals Corp.
• Sumitomo Pharma Ltd.
• VIVUS Inc
• Novartis AG
• Pfizer Inc.

Key Topics Covered:

1. Global Binge Eating Disorders Market: Industry Analysis

1.1 Market Overview and Ecosystem

1.2 Epidemiological Analysis

1.3 Key Market Trends

1.3.1 Impact Analysis

1.4 Regulatory Landscape

1.5 Pipeline Analysis

1.6 Market Dynamics

1.6.1 Overview

1.6.2 Market Drivers

1.6.3 Market Restraints

1.6.4 Market Opportunities

2. Global Binge Eating Disorders Market (by Drug Class), Value ($million), 2023-2035

2.1 Antidepressant

2.2 Anticonvulsant

2.3 Anti-obesity

2.4 Others

3. Global Binge Eating Disorders Market (by Region), Value ($Million), 2023-2035

3.1 North America

3.1.1 Market Dynamics

3.1.2 Market Sizing and Forecast

3.1.3 North America Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.1.3.1 U.S.

3.1.3.2 Canada

3.2 Europe

3.2.1 Market Dynamics

3.2.2 Market Sizing and Forecast

3.2.3 Europe Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.2.3.1 U.K.

3.2.3.2 France

3.2.3.3 Germany

3.2.3.4 Italy

3.2.3.5 Spain

3.2.3.6 Rest-of-Europe

3.3 Asia-Pacific

3.3.1 Market Dynamics

3.3.2 Market Sizing and Forecast

3.3.3 Asia-Pacific Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.3.3.1 Japan

3.3.3.2 China

3.3.3.3 India

3.3.3.4 Australia

3.3.3.5 South Korea

3.3.3.6 Rest-of-Asia-Pacific

3.4 Rest-of-the-World

3.4.1 Market Dynamics

3.4.2 Market Sizing and Forecast Rest-of-the-World Binge Eating Disorders Market, by Type ($Million), 2023-2035

3.4.3 Rest-of-the-World Binge Eating Disorders Market, by Country ($Million), 2023-2035

3.4.3.1 Latin America

3.4.3.2 Middle East and Africa

4. Competitive Landscape and Company Profiles

4.1 Competitive Landscape

4.1.1 Mergers and Acquisitions

4.1.2 Partnership, Alliances and Business Expansion

4.1.3 New Offerings

4.1.4 Regulatory Activities

4.1.5 Funding Activities

4.2 Company Profiles

4.2.1 Eli Lilly and Company

4.2.1.1 Overview

4.2.1.2 Top Products / Product Portfolio

4.2.1.3 Top Competitors

4.2.1.4 Target Customers/End-Users

4.2.1.5 Key Personnel

4.2.1.6 Analyst View

4.2.2 Amneal Pharmaceuticals, Inc.

4.2.3 Takeda Pharmaceutical, Ltd.

4.2.4 Tryp Therapeutics Inc

4.2.5 Tonix Pharmaceuticals Corp.

4.2.6 Sumitomo Pharma Ltd.

4.2.7 VIVUS Inc

4.2.8 Novartis AG

4.2.9 Pfizer Inc.

5. Research Methodology

For more information about this report visit https://www.researchandmarkets.com/r/rrk8fm

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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Alpha Cognition Inc. (Nasdaq: ACOG) Announces Participation in Key September Investor Conferences




Alpha Cognition Inc. (Nasdaq: ACOG) Announces Participation in Key September Investor Conferences

VANCOUVER, British Columbia & DALLAS–(BUSINESS WIRE)–Alpha Cognition Inc. (Nasdaq: ACOG), a commercial-stage biopharmaceutical company dedicated to developing innovative treatments for neurodegenerative diseases, today announced that Chief Executive Officer Michael McFadden will present at two prominent healthcare investor conferences this September.

• Cantor Global Healthcare Conference 2025
  Date/Time: Friday, September 5, 7:00 a.m. ET
• H.C. Wainwright & Co. Healthcare Conference 2025
  Date/Time: Tuesday, September 9, 2:00 p.m. ET

Presentation transcripts will be made available on Alpha Cognition’s website following the events and will remain accessible for 30 days.

About Alpha Cognition Inc.

Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.

ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ZUNVEYL’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI.

Forward-looking Statements

This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward-looking statement that reflects the Company’s current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “target,” “seek,” “contemplate,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company’s intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company’s filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company’s filings with the United States Securities and Exchange Commission (the “SEC”), including those risk factors under the heading “Risk Factors” in the Company’s [Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at www.sec.gov.] These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.

Contacts

Investor Relations

IR@alphacognition.com
https://www.alphacognition.com/

ZHEN-AO GROUP Unveils TRIAL RESULTS: 5′-Nucleotide Reduces DNA Methylation Age by 3.08 Years




ZHEN-AO GROUP Unveils TRIAL RESULTS: 5′-Nucleotide Reduces DNA Methylation Age by 3.08 Years

PARIS–(BUSINESS WIRE)–On August 24, 2025, the 23rd International Congress of Nutrition (ICN) convened in Paris, France, under the theme “Sustainable Food for Global Health.” As the premier platform in nutritional science, the event brought together experts from 120 countries.

At the conference, researcher Mei-Hong Xu from Peking University presented groundbreaking findings from a randomized double-blind human trial (RCT) on nucleotide-based anti-aging. The study demonstrated that 5′-nucleotide supplementation over 19 weeks reduced DNA methylation age—the gold standard for epigenetic aging—by an average of 3.08 years in 60-70-year-old participants, alongside improvements in insulin resistance and visceral fat. The 5′-nucleotides, derived from yeast hydrolysis of eukaryotic cells, were validated in the study published in the prestigious journal Advanced Science.

The research was commissioned by ZhenAo and initiated in 2006. The team pioneered a “four-generation rat” safety trial, confirming 5′-nucleotide safety while observing lifespan extensions of up to 270 days (equivalent to up to 30 human years) in rats receiving lifelong supplementation.

Building on these breakthroughs, the team launched systematic research in 2020 to explore 5′-nucleotide mechanisms in lifespan extension. Multi-level experiments—spanning whole organisms, cells, genomics, and microbiota—revealed that lifelong 5′-nucleotide intervention extended median lifespan in SAMP8 mice by 9.21% to 12.6% (almost equal to 8.76-12.01 human years).

These findings underscore 5′-nucleotide’s potential in anti-aging, offering robust scientific support for prolonging healthspan and contributing a “Chinese solution” to global longevity research.

Contacts

ZHEN-AO GROUP CO., LTD.

Wenxuan Zhang, zjx@zhen-ao.com

Compass Pathways to Participate in Four Investor Conferences in September




Compass Pathways to Participate in Four Investor Conferences in September

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the following September investor conferences:

• Cantor Global Healthcare Conference – New York, NY: Fireside chat at 1:35 PM EST on September 3, 2025
• Morgan Stanley 23rd Annual Global Healthcare Conference – New York, NY: Fireside chat at 10:45 AM EST on September 9, 2025
• H.C. Wainwright 27th Annual Global Investment Conference – New York, NY: Fireside chat at 9:00 AM EST on September 9, 2025
• TD Cowen’s 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit: Virtual fireside chat at 10:40 AM EST on September 17, 2025

A live audio webcast of these events will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthesized psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive.

Contacts

Enquiries

Media: Dana Sultan-Rothman, media@compasspathways.com, +1 484 432 0041

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

European Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025




European Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025

Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in perioperative setting in resectable non-small cell lung cancer

Broad EU label with nine approved indications in solid tumors, including five in lung cancer, highlights TEVIMBRA’s therapeutic range and strong clinical profile throughout the care continuum

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne—BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The EC approval is based on results from the Phase 3 RATIONALE-315 trial. The preplanned final analysis of RATIONALE-315 demonstrates that TEVIMBRA, combined with platinum-based chemotherapy before surgery and continued as monotherapy afterward, showed statistically significant and clinically meaningful benefit in overall survival (OS) compared with chemotherapy combined with placebo. Data from this trial will be presented as a Late-Breaking Abstract (#MA04.08)¹ at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain, September 6-9, 2025.

“Delivering a statistically significant overall survival benefit – a critical endpoint in oncology studies – alongside the European Commission’s approval of TEVIMBRA in perioperative resectable NSCLC marks a pivotal moment for patients and physicians,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. “As only the second PD-1 inhibitor to demonstrate an OS benefit in this setting, TEVIMBRA is poised to reshape lung cancer treatment in Europe.”

Building on the RATIONALE-315 results previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 2024² and published in The Lancet Respiratory Medicine³, which showed the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses, key findings from the final analysis (n=453 patients; randomized 1:1) include:

• With a median trial follow-up of 38.5 months, the TEVIMBRA-based regimen showed a statistically significant and clinically meaningful benefit in OS versus the chemotherapy + placebo arm (HR=0.65 [95% CI: 0.45, 0.93]; one-sided P=0.0093).
• The significant EFS benefit previously reported with TEVIMBRA versus chemotherapy + placebo was sustained in this analysis (HR=0.58 [95% CI: 0.43, 0.79]), and this improvement was consistent across both independent review committee (IRC) and investigator assessments, reinforcing the consistency and robustness of the findings.
• OS and EFS benefits were observed across major sub-groups, regardless of PD-L1 expression, disease stage, and histology.
• As reported at the interim analyses, the trial showed a clinically meaningful and statistically significant improvement in EFS, MPR and pathological complete response (pCR) vs. chemotherapy + placebo.
• The safety profile was consistent with the treatment components and the interim analyses. No new safety signals were identified, and the most common (≥ 10%) Grade 3 or 4 treatment-related adverse events (TRAEs) in both arms were decreased neutrophil count and decreased white blood cell count.

“Patients with resectable non-small cell lung cancer still face alarmingly high recurrence rates,” said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at Universidad Autónoma de Madrid. “The RATIONALE-315 results confirm that starting tislelizumab in the neoadjuvant phase, and continuing after surgery, has proven to be a powerful approach to improve outcomes for these patients. Now, with approval in the EU, we have a clinically validated new treatment option in the perioperative setting.”

In lung cancer, TEVIMBRA is already approved in the EU in four indications:

• first-line treatment of patients with squamous NSCLC;
• first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression;
• treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy; and
• first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

It is also approved in the EU in the following indications:

• first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma;
• first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC);
• second-line treatment in ESCC after prior platinum-based chemotherapy; and
• first-line treatment for patients with nasopharyngeal carcinoma (NPC).

About NSCLC

Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide.⁴ In Europe, lung cancer is the third most frequent cancer, with 484,306 new cases diagnosed in 2022.⁵ NSCLC accounts for 80–90% of all lung cancers⁶, of which resectable NSCLC patients at diagnosis represent around 25–30%⁷.

About RATIONALE-315

RATIONALE-315 (NCT04379635) is a randomized (1:1), double-blind, placebo-controlled, multicenter, Phase 3 trial, which evaluated TEVIMBRA neoadjuvant/adjuvant treatment in 453 adult patients with previously untreated, resectable, stage II or IIIA NSCLC. The dual primary endpoints are event-free survival (EFS) and major pathologic response (MPR). Key secondary endpoints include overall survival (OS), pathologic complete response (pCR), and disease-free survival (DFS).

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including more than 20 registration-enabling studies. TEVIMBRA is approved in 47 markets, and more than 1.7 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the impact of TEVIMBRA on lung cancer treatment in Europe; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne Medicines.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom site.

Contacts

Investor Contact
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact
Navneet Miller

+1 857-301-6440

media@beonemed.com

I2Pure and Caracal Announce Expanded Collaboration and Go-To-Market Effort for Novel Iodine Products




I2Pure and Caracal Announce Expanded Collaboration and Go-To-Market Effort for Novel Iodine Products

ASHBURN, Va.–(BUSINESS WIRE)–I2Pure and Caracal Products & Services, through its Caracal Healthcare Products division, today announce an expansion of their relationship. I2Pure’s proprietary iodine formulations and product concepts have received an overwhelmingly favorable response from Caracal’s healthcare customer base. Based on that positive feedback, I2Pure and Caracal have committed joint efforts to accelerate manufacturing and product delivery.

Three offerings make up the initial product entry: a topical iodine soak, a nasal decolonization product, and a topical iodine skin ointment. Additional products in development include surgical scrub, hand sanitizer, and several other topical iodine products.

“Since announcing our collaboration last year, Caracal has been amazed by the appetite of our healthcare customers for novel iodine products. The healthcare community clearly values the antimicrobial capability of iodine, as well as its long history of biosafety and biocompatibility,” said Don Roberts, CEO of Caracal Products & Services. “In a very short time, I2Pure’s technologies and products have become a primary interest within our healthcare customer base. We’re excited to begin marketing and delivering I2Pure products later this year.”

“A lot of hard work by our incredible team has put I2Pure in position to begin making our vision a reality. We’re thrilled to be in production now to start delivering products through Caracal later this year,” said Jeff Jochims, I2Pure CEO. “The world is ready for the next iteration of iodine chemistry. With ever-increasing antibiotic resistance and global pathogen risk, the time is right to harness the incredible antimicrobial broad-spectrum efficacy of molecular iodine, which has a time-proven safety profile and no known resistance development.”

I2Pure’s products will be available to most healthcare customers exclusively through Caracal Products & Services. Product samples will be available in September. Product delivery is expected to begin in the fourth quarter of 2025 and to expand throughout 2026.

Caracal and I2Pure expect to begin marketing products at healthcare conferences later this year, including the American Association of Hip and Knee Surgeons annual meeting in October and the National Minority Supplier Development Council’s Annual Conference & Exchange in early November in Miami.

About Caracal Products & Services: Founded in Detroit, Michigan, in 2004, Caracal is a U.S. based company with a focus on creating jobs and value in the healthcare industry through pioneering products and innovative services. As a sourcing solutions provider, Caracal offers a wide range of high-quality products and value-added services to businesses, government agencies, and educational institutions of all sizes. Caracal has cultivated strong, established partnerships in the healthcare, insurance, and financial services industries. Known for its proactive communication and stable, strategic vendor relationships, Caracal prides itself on living up to the Caracal motto each day: Supplying everything but surprises. For more information about Caracal Products & Services please visit https://www.caracalcorp.com or contact Sarah Herschelman at sherschelman@caracalcorp.com.

About I2Pure: I2Pure is an iodine technology company dedicated to advancing health and biosafety through its patented, non-toxic molecular iodine solutions. I2Pure’s mission is to prevent pathogenic threats to the world. Our technology can be utilized for countless applications across healthcare, industrial biosafety, consumer products, and food processing. The platform technology can be delivered directly or through carriers via solutions, nano particles, polymers and coatings. For more information about I2Pure, visit https://www.i2pure.com or contact the company at info@i2pure.com.

Contacts

info@i2pure.com

Acadia Pharmaceuticals to Participate at Upcoming Investor Conferences




Acadia Pharmaceuticals to Participate at Upcoming Investor Conferences

SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will participate at three upcoming investor conferences:

Morgan Stanley 23rd Annual Global Healthcare Conference

Fireside Chat: Monday, September 8, 2025 at 10:45 a.m. Eastern Time in New York, NY

H.C. Wainwright 27th Annual Global Investment Conference

Fireside Chat: Tuesday, September 9, 2025 at 8:00 a.m. Eastern Time in New York, NY

TD Cowen’s 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit

Fireside Chat: Thursday, September 18, 2025 at 1:40 p.m. Eastern Time (Virtual)

Live webcasts of each fireside chat will be accessible on the company’s website, acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neurological and rare diseases to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at acadia.com and follow us on LinkedIn and X.

Contacts

Investor Contact:
Acadia Pharmaceuticals Inc.

Al Kildani

(858) 261-2872

ir@acadia-pharm.com

Acadia Pharmaceuticals Inc.

Jessica Tieszen

(858) 261-2950

ir@acadia-pharm.com