Latest news with #COURAGE
Yahoo
3 days ago
- Business
- Yahoo
REGN Strengthens Obesity Pipeline: Will the Move Revive the Stock?
Regeneron Pharmaceuticals, Inc. REGN is looking to make inroads in the lucrative obesity market. The company recently entered into an in-licensing agreement for an obesity drug with Hansoh Pharmaceuticals Group Company Limited, in a bid to expand its clinical-stage obesity portfolio. The licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist. Regeneron will acquire exclusive clinical development and commercial rights for HS-20094, a dual GLP-1/GIP receptor agonist, outside the Chinese Mainland, Hong Kong and Macau. Per the terms of the agreement, Regeneron will make an upfront payment of $80 million to Hansoh, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones. Any royalties on global net sales in the future (outside the designated territories) would be in the low double digits. HS-20094 has been evaluated in over 1,000 patients and administered as a weekly subcutaneous injection. The candidate has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist. The candidate is currently being evaluated in a phase III study in obesity in China, and a phase IIb study in diabetes is ongoing. The in-licensing agreement for an obesity candidate will expand REGN's obesity pipeline, which includes trevogrumab. Regeneron recently announced positive interim results from the ongoing phase II COURAGE study investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity. COURAGE was designed to investigate the quality of weight loss in patients with obesity. Results showed that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of fat mass. Garetosmab is being evaluated for the treatment of fibrodysplasia ossificans progressive. The successful development of any obesity treatment will be a great boost for the company. We note that REGN has had a rough time so far this year. The stock got hammered last week after REGN and partner Sanofi SNY reported results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease (COPD). While the AERIFY-1 study met the primary endpoint, AERIFY-2 did not meet the same. REGN and SNY are currently reviewing the data and plan to discuss the next steps with regulatory authorities. Year to date, REGN's shares have lost 31.7% compared with the industry's 3.2% decline. Image Source: Zacks Investment Research Regeneron's performance in the first quarter was dismal. The plunge in Eylea sales adversely impacted the top line. Eylea sales have been under pressure for some time now due to competition from Roche's Vabysmo. Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote Regeneron has a tough road ahead, as it will take a long time for Eylea HD to contribute significantly to the top line. Apart from Eylea, profits from the sales of asthma drug Dupixent are a primary growth driver for REGN. Regeneron has a collaboration agreement with Sanofi for Dupixent. While the obesity market is lucrative, REGN is a pretty late entrant here. The market is dominated by bigwigs like Novo Nordisk NVO and Eli Lilly LLY. The stupendous success of Novo Nordisk's obesity drug, Wegovy (semaglutide) and Eli Lilly's Zepbound has prompted many companies to join the bandwagon. Buoyed by this success, both Lilly and NVO have taken significant strides in developing their obesity portfolios further. Given the significant market potential of obesity, other players are also striving to grab a chunk of this pie. Regeneron currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Novo Nordisk A/S (NVO) : Free Stock Analysis Report Eli Lilly and Company (LLY) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Yahoo
6 days ago
- Business
- Yahoo
Regeneron Expands Clinical-Stage Obesity Portfolio with Strategic In-Licensing of Novel Dual GLP-1/GIP Receptor Agonist
New licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist in advanced stages of clinical development in China Phase 2 data suggest potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist Key complementary asset enables synergy and flexibility across Regeneron's broad pipeline of obesity and metabolic programs focused on improved quality of weight loss, co-morbidities and long-term health TARRYTOWN, N.Y., June 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a strategic in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited ('Hansoh') to acquire exclusive clinical development and commercial rights outside of the Chinese Mainland, Hong Kong and Macau for a dual GLP-1/GIP receptor agonist currently in Phase 3 testing. This novel therapeutic candidate (HS-20094) – studied in over 1,000 patients and administered as a weekly subcutaneous injection – has demonstrated promising efficacy and safety clinical data, suggesting a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist. A Phase 3 trial in obesity in China and Phase 2b study in diabetes are ongoing. Under the terms of the agreement, Regeneron will make an upfront payment to Hansoh of $80 million, with potential additional payments of up to $1.93 billion for achievement of development, regulatory and sales milestones. Future potential royalties for global net sales outside of the designated territories would be in the low double digits. 'Regeneron is committed to advancing better obesity treatments by enhancing quality of weight loss,' said George Yancopoulos, M.D., Ph.D., co-Chair, President and Chief Scientific Officer of Regeneron. 'Despite the transformative impact of recent weight loss therapies, significant unmet needs remain, including the ability to sustain weight loss and maintain muscle mass over time. Securing access to a GLP-1/GIP receptor agonist will increase the versatility of our clinical programs for obesity and accelerate our mission to support quality, sustained weight loss and the associated long-term health benefits.' 'In-licensing a late-stage GLP1/GIP agonist will allow us to study combinations with Regeneron's proprietary drugs and drug candidates in order to holistically address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes and liver conditions,' said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. 'This is an exciting development in our obesity work at Regeneron, which also includes the muscle-sparing Phase 2 COURAGE study investigating the addition of trevogrumab, our GDF8 antibody to semaglutide, with and without garetosmab, our anti-activin antibody. Interim data from this study was announced earlier today.' This agreement is subject to customary closing conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States. About Regeneron in Obesity Obesity is a complex, multifaceted disease and a growing public health concern that affects more than a billion people worldwide. Despite the revolutionary impact of GLP-1 receptor agonists (GLP-1RAs) on weight loss, the quality of this weight loss can be negatively impacted because these agents can cause profound muscle loss. Moreover, a high percentage of patients cycle on and off treatment – and while off treatment they can regain almost all of the weight lost, but mostly in the form of fat, leaving them with negatively altered body composition. At Regeneron, we are developing a pipeline focused on the quality of weight reduction. We have several independent approaches focused on promoting and preserving muscle during weight loss, so as to increase the amount of fat loss since adiposity is the principal driver of comorbidities and metabolic diseases associated with obesity. In addition, Regeneron has an extensive pipeline of agents to address some of these co-morbidities and metabolic diseases, which have the potential to be combined with GLP-1RAs. The combination of our science, pipeline, research and clinical innovation uniquely positions us to make a meaningful difference in obesity and obesity-related diseases. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron' or the 'Company'), and actual events or results may differ materially from these forward-looking statements. Words such as 'anticipate,' 'expect,' 'intend,' 'plan,' 'believe,' 'seek,' 'estimate,' variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, those relating to Regeneron's in-licensing agreement with Hansoh Pharmaceuticals Group Company Limited ('Hansoh') to acquire exclusive clinical development and commercial rights outside of China for HS-20094 (a dual GLP-1/GIP receptor agonist) as discussed in this press release (the 'In-Licensing Transaction'); the likelihood and timing of the closing of the In-Licensing Transaction, including the possibility that the applicable closing conditions for the In-Licensing Transaction may not be satisfied or waived (such as regulatory approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976); risks related to Regeneron's ability to realize the anticipated benefits of the In-Licensing Transaction, including the possibility that the expected benefits from the In-Licensing Transaction will not be realized or will not be realized within the expected time period; significant transaction costs and unknown liabilities; the risk of litigation and/or regulatory actions related to the In-Licensing Transaction; the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron Product Candidates') and research and clinical programs now underway or planned, including without limitation the planned clinical programs investigating HS-20094 in combination with other Regeneron Product Candidates to address muscle loss and other comorbidities of obesity (such as cardiovascular diseases, diabetes, and liver conditions) as discussed in this press release as well as Regeneron's other clinical programs focused on the quality of weight reduction (such as the clinical program investigating the addition of trevogrumab to semaglutide, with and without garetosmab) referenced in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products and Regeneron Product Candidates (such as those referenced above); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron Product Candidates and new indications for Regeneron's Products, such as those referenced above; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products and Regeneron Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron Product Candidates in clinical trials; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron Product Candidates (including biosimilar versions of Regeneron's Products); unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) and Regeneron's agreement with Hansoh as discussed in this press release, to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024, and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Contacts:Media Relations Mary HeatherMedia@ Investor RelationsRyan CroweInvest@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
29-04-2025
- Health
- Associated Press
Sumitomo Pharma America Presents New Data on Vibegron at the 2025 American Urological Association Annual Meeting
– Data include results from COURAGE Phase 3 and COMPOSUR Phase 4 studies of vibegron (GEMTESA®) – MARLBOROUGH, Mass., April 29, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) presented new, positive data from the COURAGE Phase 3 open-label extension study of vibegron (GEMTESA®) in men living with overactive bladder (OAB) and receiving pharmacological therapy for benign prostatic hyperplasia (BPH). Data presented from the Phase 3 COURAGE trial (URO-901-3006) included a total of 276 men with OAB symptoms receiving pharmacological therapy for BPH who participated in the open-label extension study. The primary outcome was to evaluate the long-term safety of vibegron 75 mg, which was well tolerated for up to 52 weeks in men with symptoms of OAB who were receiving pharmacological treatment for BPH. The data reveal that the efficacy results of treatment with vibegron 75 mg a day were sustained among those receiving vibegron for 52 weeks and improved after 28 weeks of vibegron treatment for those who received placebo during the first 12 weeks of a double-blind placebo-controlled study (URO-901-3005). Sustained efficacy results in all secondary outcomes were observed, including mean daily micturitions, urgency episodes, nocturia episodes, urge urinary incontinence episodes, IPSS-Storage and volume voided per micturition. Vibegron demonstrated favorable long-term safety and efficacy, with no new safety signals compared to prior OAB studies. At the conference SMPA also shared findings from the Phase 4 COMPOSUR, real-world study of vibegron in patients with OAB, which continue to support that it was generally safe and well-tolerated, with the majority of patients satisfied with treatment and remaining on vibegron after 12 months. Most common adverse events were urinary tract infection (4.0%), headache (2.7%), dizziness (2.2%) and diarrhea (2.0%). 'SMPA remains committed to advancing scientific innovation that helps the lives of the millions of patients suffering from OAB and receiving pharmacological therapy for BPH,' said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. 'These data continue to reaffirm vibegron's safety and tolerability.' Vibegron is approved for OAB with symptoms of urge urinary incontinence, urgency and urinary frequency in adults, and in December 2024, became the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred. WARNINGS AND PRECAUTIONS Urinary Retention Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention. Angioedema Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway. ADVERSE REACTIONS Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection. INDICATIONS AND USAGE GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of: Please click here for full Prescribing Information. About GEMTESA® (vibegron) In the U.S., GEMTESA (vibegron) has been indicated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA was approved on December 18, 2024, for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). GEMTESA works by selectively targeting β3 adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity. About Overactive Bladder Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours).7 Approximately 33 million U.S. adults experience the bothersome symptoms of OAB.1 About Benign Prostatic Hyperplasia Benign prostatic hyperplasia (BPH) is a condition in men in which the prostate gland is enlarged. Many men who are treated for symptoms are assumed to have an obstruction in the bladder caused by an enlarged prostate.4, 5 Even when the obstruction is alleviated by BPH treatment, unresolved symptoms of OAB may persist. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS).4, 5 LUTS can be divided into storage, voiding, and postmicturition symptoms.8 More than half of men with LUTS report storage symptoms, and about a quarter report voiding symptoms.5 This suggests that many men with a diagnosis of BPH may have overactive bladder.5 About Sumitomo Pharma Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. The Sumitomo corporate symbol mark is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO PHARMA is a trademark of Sumitomo Pharma Co., Ltd., used under license. SUMITOMO is a registered trademark of Sumitomo Chemical Co., Ltd., used under license. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. GEMTESA, and the GEMTESA logo are trademarks of Urovant Sciences GmbH, registered in the U.S. and in other countries. ©2025 Sumitomo Pharma America, Inc. All rights reserved. References View original content to download multimedia: SOURCE Sumitomo Pharma America
