Acceleron Pharma, Inc.

BOSTON and SAN DIEGO, June 05, 2025 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity and related conditions, today announced the appointments of Adam Koppel and Christopher Hite to its Board of Directors. “We are thrilled to welcome Adam and Chris to our Board of Directors. Their extensive track records as respected advisors to biopharma companies on corporate and financial strategy will be incredibly valuable as we continue to execute on our mission to advance next-generation therapies for the treatment of obesity,” said Ron Renaud, President and Chief Executive Officer, Kailera. “It’s an exciting time to join Kailera’s Board as they progress their pipeline toward late-stage global trials, and I look forward to contributing to the company’s continued success and long-term value creation,” said Dr. Koppel. Mr. Hite added, “I am pleased to join the Board of Kailera at this important time of innovation in the obesity space that has positively impacted millions of patients worldwide. Kailera has a clear strategy to advance their diversified pipeline, and I look forward to supporting the leadership team as they work towards achieving their mission.” Dr. Koppel is a distinguished investor and strategic leader with more than 25 years of biopharmaceutical industry experience. He is a Partner on Bain Capital’s Life Sciences team and initially joined Bain Capital in 2003. Previously, Dr. Koppel was EVP of Corporate Development and Chief Strategy Officer at Biogen. He currently sits on the Board of Directors of Areteia Therapeutics and Cardurion Pharmaceuticals and serves on the Board of Trustees at Newton Wellesley Hospital. Dr. Koppel also co-chairs the Harvard Medical School Discovery Council and serves on the Mass General Brigham Innovation Growth Board. He received an M.D. and Ph.D. in Neuroscience from the University of Pennsylvania School of Medicine. Dr. Koppel also received an M.B.A. from The Wharton School at the University of Pennsylvania, where he was a Palmer Scholar, and graduated magna cum laude from Harvard University with an A.B. and A.M. in History and Science. Mr. Hite, a seasoned financial executive with over 25 years of financial and strategic experience in the biopharmaceutical industry, will serve as an independent board member and audit committee chair. Mr. Hite currently serves as Executive Vice President and Vice Chairman at Royalty Pharma. Prior to joining Royalty Pharma in 2020, he was at Citibank for over a decade, serving most recently as Vice Chairman of Banking, Capital Markets and Advisory (BCMA) and a member of the BCMA Executive Committee, and previously as the Global Head of Healthcare Investment Banking. Prior to joining Citibank, Mr. Hite was the Global Head of Healthcare Investment Banking at Lehman Brothers. He serves on the Board of Trustees at Lehigh University, the Board of Advisors of Faster Cures, a center of the Milken Institute, and served on the Board of Directors of Acceleron Pharma Inc. until its acquisition by Merck in November 2021. Mr. Hite has a B.S. from Lehigh University, and a J.D. and M.B.A. from the University of Pittsburgh. About Kailera Therapeutics Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that has demonstrated positive results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com and follow us on LinkedIn and X. Contact Information Maura Gavaghan Vice President, Corporate Communications and Investor Relations maura.gavaghan@kailera.com

New data unveiled Monday showed that Merck’s Winrevair can significantly cut the risk of death, lung transplantation and hospitalization in patients with a rare form of high blood pressure in the lungs, potentially providing a boost to sales. The data come from a study that was stopped early for overwhelming efficacy in November . However, this early halt meant that a secondary endpoint looking at deaths alone faced a higher bar and did not meet statistical significance. It is now unclear whether Winrevair, which was approved for pulmonary arterial hypertension (PAH) around a year ago , will be able to get a specific mortality claim on its label as the company had previously hoped. What is clear is that the trial, named ZENITH, scored a huge success on its primary endpoint. Winrevair, an injected activin receptor fusion protein, reduced a composite of all-cause death, lung transplantation and hospitalization for PAH by 76% compared with placebo. Of those given Merck’s drug, 17.4% experienced one or more of these major morbidity and mortality events, versus 54.7% of those given placebo. ZENITH enrolled 172 adults with advanced PAH who were at high risk of mortality and were on maximum tolerated background therapy. This finding, presented at the American College of Cardiology’s Annual Scientific Sessions, is important because Winrevair’s approval was based on softer endpoints, including improving patients’ exercise capacity and symptoms. Evidence of a more concrete effect on patients’ health could extend the drug’s reach. “Four to five weeks after initiation of [Winrevair] there’s already a detectable difference in deaths, hospitalization and lung transplant between both groups,” Joerg Koglin, senior VP of global clinical development at Merck, told Endpoints News . “That’s an endpoint that was never tackled by any other PAH drug development program,” he added. However, the crucial secondary endpoint of overall survival was not met. There were seven deaths in the Winrevair arm compared with 13 in the placebo arm, but the statistical threshold here was set at a p-value of 0.0021, a harder bar to hit than the more usual 0.05. Koglin said that this tougher standard was a statistical necessity when interim analyses are used. The actual p-value for mortality at the interim point was 0.0313. “If we would’ve seen that p-value at the end of the study, of course that would’ve been significant,” he said. When examined individually, the other components of the composite endpoint also favored Merck’s drug, though again the company was unable to claim statistical significance. One Winrevair patient had a lung transplant compared with six in the placebo arm, and eight patients in the drug group were hospitalized for PAH versus 43 — half the patients — in the placebo group. Safety was consistent with earlier studies, such as the STELLAR trial which led to Winrevair’s approval. The group will submit the ZENITH data to the FDA and other agencies, and Koglin said that “one of the discussions with regulators would be if the survival benefit should be spelled out more clearly in the label.” Whether a mortality benefit is added to the label or not, sales could see an uptick. With Winrevair, Koglin said, “you see an impact on hard endpoints and there is no other program out there that ever has shown a similar effect. It will be a strong argument for a physician to consider [Winrevair] for a given patient.” Merck confirmed that it does not anticipate a price increase for Winrevair even if the drug does receive a label update. Winrevair was one of the two main products behind Merck’s $11.5 billion acquisition of Acceleron in 2021 . The drug had sales of $419 million last year. The other main reason for the Acceleron deal was the blood disorder therapy Reblozyl, which sold $371 million in 2024. Winrevair sales will have to grow if Merck is to make its money back.

The increasing prevalence of chronic conditions like cardiovascular disease is driving the demand for transmucosal drugs. Key factors contributing to the transmucosal drugs market's growth from 2025 to 2032 include the rising adoption of these drugs, along with growing research and development efforts and collaborations among major industry players. LAS VEGAS, Feb. 18, 2025 /PRNewswire/ -- DelveInsight's Transmucosal Drugs Market Insights report provides the current and forecast market analysis, individual leading transmucosal drugs companies' market shares, challenges, transmucosal drugs market drivers, barriers, trends, and key market transmucosal drugs companies in the market. Key Takeaways from the Transmucosal Drugs Market Report As per DelveInsight estimates, North America is anticipated to dominate the global transmucosal drugs market during the forecast period. In the product segment of the transmucosal drugs market, the tablet category had a significant revenue share in the transmucosal drugs market in 2024. Notable transmucosal drugs companies such as Teva Pharmaceutical Industries Ltd, Indivior PLC, GSK plc, Emergent BioSolutions Inc., Bayer AG, AbbVie Inc., Organon group of companies, Pfizer Inc., Prestige Consumer Healthcare, Inc., Merck & Co., Inc., Aquestive Therapeutics, Inc., Ferring, Novartis AG, Adalvo Limited, Sumitomo Pharma Co., Ltd., ZIM LABORATORIES LIMITED, BioXcel Therapeutics, Inc., BIAL, Almac Group, Boehringer Ingelheim International GmbH, and several others, are currently operating in the transmucosal drugs market. In March 2024, BIAL launched KYNMOBI (apomorphine hydrochloride) in Germany. KYNMOBI is the sublingual film for the intermittent treatment of OFF episodes in adult patients with Parkinson's disease. In March 2024, Tonix Pharmaceuticals announced its collaboration with Almac Pharma Services for the launch and commercialization of TonmyaTM (cyclobenzaprine HCl sublingual tablets) in the U.S. Tonmya is a centrally acting opioid analgesic for the treatment of fibromyalgia. To read more about the latest highlights related to the transmucosal drugs market, get a snapshot of the key highlights entailed in the Global Transmucosal Drugs Market Report Transmucosal Drugs Overview Transmucosal drugs are a category of medications designed to be absorbed through mucous membranes, such as those found in the mouth, nasal passages, or gastrointestinal tract. These drugs are typically formulated as lozenges, films, sprays, or tablets that dissolve upon contact with mucosal surfaces. The primary advantage of transmucosal drug delivery is its ability to bypass the digestive system, leading to faster absorption and onset of action compared to oral administration. This can be particularly beneficial for drugs that are poorly absorbed through the gastrointestinal tract or those that need to act quickly, such as pain relief medications or treatments for acute conditions. The transmucosal route can offer increased bioavailability, as the drug is absorbed directly into the bloodstream through the mucosal membranes, often avoiding first-pass metabolism in the liver. This can reduce the required dosage and minimize side effects. Additionally, transmucosal drug delivery systems are typically non-invasive and convenient for patients, making them an attractive option for chronic treatments or for populations that may struggle with traditional oral medications, such as pediatric or geriatric patients. However, this form of drug delivery requires careful formulation to ensure proper drug release, stability, and patient adherence. Transmucosal Drugs Market Insights North America is projected to hold the largest share of the transmucosal drugs market in the coming years compared to other regions. This growth is primarily driven by the increasing prevalence of chronic conditions such as hypertension and neurological diseases, alongside the growing research and development efforts by major industry players. Notable market players are focusing on creating innovative treatments for neurological disorders. For example, in April 2022, BioXcel Therapeutics, Inc. received approval from the U.S. Food and Drug Administration (FDA) for IGALMITM (dexmedetomidine) sublingual film to treat acute agitation linked to schizophrenia or bipolar I or II disorder in adults. These advancements in drug development are expected to further boost market expansion in North America. Thus, the rising incidence of chronic diseases and the introduction of new products by key players are key drivers of the transmucosal drugs market growth in the region. To know more about why North America is leading the market growth in the transmucosal drugs market, get a snapshot of the Transmucosal Drugs Market Outlook Transmucosal Drugs Market Dynamics The transmucosal drugs market has been witnessing significant growth, driven by its ability to offer an effective and less invasive alternative to conventional drug administration methods. Transmucosal delivery involves the absorption of therapeutic agents through mucous membranes, such as the nasal, buccal, or sublingual areas. This method bypasses the digestive system, allowing for faster onset of action and enhanced bioavailability, particularly for drugs that are poorly absorbed through the gastrointestinal tract. The demand for this delivery method is particularly prominent in the management of conditions that require rapid symptom relief, such as acute pain, migraine, and anxiety disorders. Technological advancements play a key role in the dynamics of the transmucosal drugs market. Innovations such as nanoparticles, liposomes, and microneedles are improving the efficiency and accuracy of drug delivery systems. For example, the development of nasal sprays and sublingual tablets has revolutionized the administration of both peptide and non-peptide drugs. These technologies not only enhance drug absorption but also help in reducing side effects by targeting specific areas in the body. Moreover, the ease of administration and the patient-friendly nature of these systems have made them a preferred choice, particularly in the pediatric and geriatric populations. Additionally, market growth is supported by an increasing demand for personalized medicine. As treatments become more tailored to individual patient needs, transmucosal delivery systems provide an effective way to fine-tune drug doses and achieve optimal therapeutic outcomes. For instance, the ability to deliver drugs directly into the bloodstream through the mucosal membranes allows for better control over drug release rates, which is particularly important for chronic conditions requiring long-term management. This shift towards more personalized treatments has been further augmented by the rise of digital health technologies, such as remote monitoring tools that ensure patients adhere to their prescribed treatments. Despite the many advantages, the transmucosal drugs market also faces challenges. The high cost of research and development, coupled with regulatory hurdles for new drug delivery systems, can impede market expansion. Furthermore, the potential for irritation or infection at the site of drug administration, particularly for chronic use, remains a concern. As a result, manufacturers must invest in developing more user-friendly, efficient, and safer products to maintain consumer trust. Overall, while the transmucosal drugs market shows great promise, the need for continuous innovation and rigorous safety standards will be critical for its sustained growth. Get a sneak peek at the transmucosal drugs market dynamics @ Transmucosal Drugs Market Dynamics Analysis Transmucosal Drugs Market Assessment Transmucosal Drugs Market Segmentation Transmucosal Drugs Market Segmentation By Product: Nasal Spray, Tablet, Film, and Others Transmucosal Drugs Market Segmentation By Route of Administration: Oral, Nasal, Sublingual, Buccal, and Others Transmucosal Drugs Market Segmentation By Distribution Channel: Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy Transmucosal Drugs Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the transmucosal drugs market are set to emerge as the trendsetter explore @ Transmucosal Drugs Companies Table of Contents Interested in knowing the transmucosal drugs market by 2032? 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