{"success":true,"data":{"pressRelease":{"id":"158570","rtpr_id":"nGNXbpVm3B-20261001","ticker":"REGN","exchange":"NASDAQ","all_tickers":["REGN"],"title":"Phase 2 COURAGE Trial Confirms Trevogrumab Prevents Lean Mass and Muscle Loss During GLP-1 Receptor Agonist-induced Weight Loss ","author":"Globe Newswire","published_at":"2026-10-01T15:30:00.255Z","article_body":"In a predefined MRI substudy, trevogrumab prevented 70% of muscle loss\nassociated with semaglutide treatment \n\nA pre-specified subgroup analysis found that patients meeting the low lean\nmass definition for sarcopenia had greater loss of lean mass with semaglutide,\nand more preservation with trevogrumab\n\nFindings were presented at the European Association for the Study of Diabetes\n(EASD) Annual Meeting and is in press with The Lancet\n\nTARRYTOWN, N.Y., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,\nInc. (NASDAQ: REGN) today announced new results from the Phase 2 COURAGE trial\nevaluating trevogrumab (anti-GDF8/anti-myostatin) for its potential to prevent\nlean mass and muscle loss during GLP-1 receptor agonist-induced weight loss in\npeople living with obesity. The results of the trial were presented during a\nScientific Symposium at the European Association for the Study of Diabetes\n(EASD) Annual Meeting and is in press with The Lancet. Building on these\npositive findings, Regeneron is planning to initiate a Phase 2 trial\nevaluating trevogrumab in combination with GLP-1 receptor agonist-based\ntherapies in older adults with obesity and decreased muscle mass and/or\nstrength.\n\n“COURAGE demonstrated that trevogrumab, which blocks myostatin, can preserve\nlean mass and muscle during semaglutide-induced weight loss,” said Julio\nRosenstock, M.D., Lead Principal Investigator of the COURAGE trial and\nClinical Professor of Medicine, University of Texas Southwestern Medical\nCenter, Dallas. “These results, sustained through a full year of treatment,\nwere further validated by MRI measurements of muscle volume supporting\ncontinued clinical development of trevogrumab and future research into muscle\npreservation as part of obesity care.”\n\nCOURAGE investigated the quality of weight loss in people living with obesity\n(BMI ≥30 kg/m(2)) in two independent portions over 52 weeks. A higher-dose\nportion evaluated trevogrumab (200 mg or 400 mg) in combination with\nsemaglutide 2.4 mg for 26 weeks compared to semaglutide alone, and then\ntrevogrumab compared to placebo alone for an additional 26 weeks after\nsemaglutide was discontinued. The trial also included a treatment arm with\nsemaglutide, trevogrumab and an Activin-A inhibitor for which the results were\npreviously presented\n(https://www.globenewswire.com/Tracker?data=C9zE6Pxj7lY1skXO5T_aAwAcLGQWemu2qWFlvpHkZciKYrJ6DZ9zEiRbWwuCEp-jyd3mD6hVopeeUnjC6ZrH2QYDZ8WwVwkJ7b_aT_XbXsrdua2DMZSBHEMNE0D22WQMkgRlo5T6TnwGJUKJApzNKb7bMnhsw6A-gte0iO-XR6_nmzFJSoiLPtTco1KfrpWTUskMYUqfyKAzQn-HQu_PH_sme7CdrA0CH96sG4MN8Lg=).\n\nA lower-dose portion evaluated trevogrumab (25 mg or 75 mg) in combination\nwith semaglutide 2.4 mg compared to semaglutide monotherapy for 52 weeks. The\nresults in this portion replicated the findings of the higher-dose portion,\nwith the greatest reduction in lean mass occurring during the period of most\nrapid weight loss that was observed in the first six months of treatment.\nWhile lower-dose trevogrumab did not meaningfully enhance the weight loss\nachieved with semaglutide alone, it preserved lean mass at both 26 and 52\nweeks (the primary endpoint), compared to placebo, as outlined in the table\nbelow:\n\n Percent change in lean mass from baseline as measured by DXA                                                                                               \n Arm                              26 weeks                                                     52 weeks                                                     \n Placebo + semaglutide            -6.7% (95% CI: -7.9 to -5.5)                                 -7.3% (95% CI: -8.8 to -5.8)                                 \n Trevogrumab 25 mg + semaglutide  -4.7% (95% CI: -5.5 to -3.9)  29.9% lean mass preservation*  -5.8% (95% CI: -6.8 to -4.7)  20.5% lean mass preservation*  \n Trevogrumab 75 mg + semaglutide  -3.3% (95% CI: -4.1 to -2.4)  50.7% lean mass preservation*  -4.2% (95% CI: -5.3 to -3.1)  42.5% lean mass preservation*  \n\n*Relative to placebo + semaglutide\n\nAmong participants with evaluable MRI data, lower dose trevogrumab preserved\nalmost 70% of the thigh muscle that would have been otherwise lost with\nsemaglutide treatment alone, as outlined in the table below:\n\n Absolute change from baseline in fat free muscle volume (mean ± standard error) as measured by MRI                     \n Arm                              26 weeks                                   52 weeks                                   \n Placebo + semaglutide            -0.88 ± 0.21                               -1.03 ± 0.22                               \n Trevogrumab 25 mg + semaglutide  -0.32 ± 0.14  63.6% muscle preservation*   -0.29 ± 0.12  71.8% muscle preservation*   \n Trevogrumab 75 mg + semaglutide  -0.24 ± 0.13  72.7% muscle preservation*   -0.32 ± 0.13  68.9% muscle preservation*   \n\n*Relative to placebo + semaglutide\n\nThe lower doses of trevogrumab were generally well tolerated, with 77% of\nparticipants experiencing at least one adverse event (AE), compared with 82%\nof those who were treated with placebo. The most common AEs occurring in\n≥10% of patients were nausea, constipation, diarrhea and vomiting.\n\nAlso presented at EASD was a pre-specified subgroup analysis of participants\nwith low lean mass (LLM) at baseline. Compared to patients without LLM at\nbaseline, these patients experienced a greater loss of lean mass with\nsemaglutide alone and numerically more preservation of lean mass in\ncombination with trevogrumab. LLM was defined using the imaging component of\nthe sarcopenia definition established by the Foundation for the National\nInstitutes of Health (appendicular lean mass relative to BMI, measured by\nDXA).\n\n“As GLP-1 receptor agonist-based medicines become foundational to obesity\ncare, it is becoming increasingly recognized that the associated muscle loss\nis an increasing concern – particularly for people with sarcopenia, older\nadults and others where frailty is a real concern,” said Boaz Hirshberg,\nM.D., Senior Vice President, Clinical Development, Internal Medicine,\nRegeneron. “Our COURAGE trial not only confirms this concern about muscle\nloss but also shows that trevogrumab can be part of the solution, addressing\nnot the quantity, but rather the quality, of weight loss. It’s an approach\nwe’re building across our growing pipeline.”\n\nAdditionally, Hansoh presented data from their Phase 3 trial in Chinese\npatients evaluating olatorepatide for the treatment of adults with obesity or\nwho are overweight. Olatorepatide is a novel GLP-1/GIP receptor agonist for\nwhich Regeneron has exclusive clinical development and commercial rights\noutside of the Chinese Mainland, Hong Kong and Macau as part of a\nstrategic in-licensing agreement.\n\nThe safety and efficacy of trevogrumab and olatorepatide have not been\nevaluated by any regulatory authority.\n\nAbout Regeneron in Obesity \nObesity is a complex, multifaceted disease and a growing public health\nconcern that affects more than a billion people worldwide. Despite the\nrevolutionary impact of GLP-1 receptor agonists (GLP-1RAs) on weight loss, the\nquality of this weight loss can be negatively impacted because these agents\ncan cause profound muscle loss. \nAt Regeneron, we are developing a pipeline focused on the quality of weight\nreduction. We have several independent approaches focused on promoting and\npreserving muscle during weight loss, so as to increase the amount of fat loss\nsince adiposity is the principal driver of comorbidities and metabolic\ndiseases associated with obesity. In addition, Regeneron has an extensive\npipeline of agents to address some of these co-morbidities and metabolic\ndiseases, which have the potential to be combined with GLP-1RAs. The\ncombination of our science, pipeline, research and clinical innovation\nuniquely positions us to make a meaningful difference in obesity and\nobesity-related diseases.  \n\nAbout Regeneron\nRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents,\ndevelops and commercializes life-transforming medicines for people with\nserious diseases. Founded and led by physician-scientists, our unique ability\nto repeatedly and consistently translate science into medicine has led to\nnumerous approved treatments and product candidates in development, most of\nwhich were homegrown in our laboratories. Our medicines and pipeline are\ndesigned to help patients with eye diseases, allergic and inflammatory\ndiseases, cancer, cardiovascular and metabolic diseases, neurological\ndiseases, hematologic conditions, infectious diseases, and rare diseases.\n\nRegeneron pushes the boundaries of scientific discovery and accelerates\ndrug development using our proprietary technologies, such\nas VelociSuite(®), which produces optimized fully human antibodies and new\nclasses of bispecific antibodies. We are shaping the next frontier of\nmedicine with data-powered insights from the Regeneron Genetics\nCenter(®) and pioneering genetic medicine platforms, enabling us to\nidentify innovative targets and complementary approaches to potentially treat\nor cure diseases.\nFor more information, please visit www.Regeneron.com or follow Regeneron on\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=gTyV7byn7joDZWD5iBWvnfKodMMsalS7cNl2z896cDrp4VELCMUi-B15mgyvXkRwaIWH4JUPC68fW8JM9BLAFEZJw80NxAnRj4mjcUa00MNKC5zuaEkXKeoaNiSwOPx48xFR7TiNqvkkaOhvKDQTVehoOlHXXS6TcbRAuy5guY065BKxubYzrXoqZ_9hbEUFWKrqgdXueIwTRfY2O72pZudnLxIWD8ij_i20D5R9iZvHgo2EHHT0tChJ6B-N-Uysvlx_ITIHx4an6amgiCXXQw==),\nInstagram\n(https://www.globenewswire.com/Tracker?data=T3vFTXJNkvzAMr4xM95V2PuHx4A1dEgorJg2oaDlvxwU-Vg80yUc2NgEim8ohxYO-_Pu1PdshU1KX0Ykvl6CNLSRPAtki7uD3EJU34dVO9TRJ3t46k5g9Zy9O9lLlSA3kq0foM9BO_iRce_dk2WPpQBQYEWKJ6vp38zQUQFR6XO6AVNgN4KFzisdbr3NEU0KdaDkdgG2FvdpRLzbJoOg_MzE2ITe43SJHSe5dQAFWIPNz7-YKr8pyLgP30Ww4uGT),\nFacebook\n(https://www.globenewswire.com/Tracker?data=kGk0lPV8cJzYZaxoJyB-S0AwJ8EoJsSJqPUOc5ESPJmbsuJBS-1zqLDoeMb_-GokY8b-hykFhh8Oouo03sNrZmVvCHGZTeOoG2tJO5x0FaxhaCO4gS-vqq2SpXznND05Rkyim3RvvVArDxMfnEuEbIxRmCPK4T38W-6dlBpRlj_u4fMif3tqEWmAPErvEuo-DfnN9z-PHEZb4IEO1yNtwOUzWc16CRHSfph1Z4TJq68auSapeRa-peXruegvXNFx)\nor X\n(https://www.globenewswire.com/Tracker?data=uv3T66n0Q1UYPuPAawzMWFfIaNXdRsxkjN29A1vAcbxscjmwLdiljd-Wvmlq1c7uEHeQKVTRq75qllbUyJUVhcbwTZgjHxU1bc0WJekXEKmy7YP0m44S-TmsGTN-dRJlFSTa7j4iLGoRz9R2ia68TMRxGXAFVa_lfcE7O-FriNjN3DFEHBci2RjOHVzzev-zNKR4YLgfjmE2igG3uvJHZA==).\n\nForward-Looking Statements and Use of Digital Media \nThis press release includes forward-looking statements that involve risks and\nuncertainties relating to future events and the future performance of\nRegeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and\nactual events or results may differ materially from these forward-looking\nstatements. Words such as “anticipate,” “expect,” “intend,”\n“plan,” “believe,” “seek,” “estimate,” variations of such\nwords, and similar expressions are intended to identify such forward-looking\nstatements, although not all forward-looking statements contain these\nidentifying words. These statements concern, and these risks and uncertainties\ninclude, among others, the nature, timing, and possible success and\ntherapeutic applications of products marketed or otherwise commercialized by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Products”) and product candidates being developed by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Product Candidates”) and research and clinical programs now\nunderway or planned, including without limitation the clinical programs\ndiscussed or referenced in this press release evaluating trevogrumab\n(anti-GDF8/anti-myostatin) in combination with semaglutide or other GLP-1\nreceptor agonist-based therapies to prevent lean mass and muscle loss during\nGLP-1 receptor agonist-induced weight loss as well as olatorepatide as a\nmonotherapy for the treatment of adults with obesity or who are overweight;\nuncertainty of the utilization, market acceptance, and/or commercial success\nof Regeneron’s Products and Regeneron’s Product Candidates and the impact\nof studies (whether conducted by Regeneron or others and whether mandated or\nvoluntary), including the studies discussed or referenced in this press\nrelease, on any of the foregoing or any potential regulatory approval of\nRegeneron’s Products and Regeneron’s Product Candidates (such as those\nreferenced above); the likelihood, timing, and scope of possible regulatory\napproval and commercial launch of Regeneron’s Product Candidates and new\nindications for Regeneron’s Products, such as those referenced above; the\nability of Regeneron’s collaborators, licensees, suppliers, or other third\nparties (as applicable) to perform manufacturing, filling, finishing,\npackaging, labeling, distribution, and other steps related to Regeneron’s\nProducts and Regeneron’s Product Candidates; the ability of Regeneron to\nmanage supply chains for multiple products and product candidates and risks\nassociated with tariffs and other trade restrictions; safety issues resulting\nfrom the administration of Regeneron’s Products and Regeneron’s Product\nCandidates (such as those referenced above) in patients, including serious\ncomplications or side effects in connection with the use of Regeneron’s\nProducts and Regeneron’s Product Candidates in clinical trials;\ndeterminations by regulatory and administrative governmental authorities which\nmay delay or restrict Regeneron’s ability to continue to develop or\ncommercialize Regeneron’s Products and Regeneron’s Product Candidates;\nongoing regulatory obligations and oversight impacting Regeneron’s Products,\nresearch and clinical programs, and business, including those relating to\npatient privacy; the availability and extent of reimbursement or copay\nassistance for Regeneron’s Products from third-party payors and other third\nparties, including private payor healthcare and insurance programs, health\nmaintenance organizations, pharmacy benefit management companies, and\ngovernment programs such as Medicare and Medicaid; coverage and reimbursement\ndeterminations by such payors and other third parties and new policies and\nprocedures adopted by such payors and other third parties; changes to drug\npricing regulations and requirements and Regeneron’s pricing strategy,\nincluding in connection with Regeneron’s April 2026 agreements with the U.S.\ngovernment; other changes in laws, regulations, and policies affecting the\nhealthcare industry; competing products and product candidates (including\nbiosimilar products) that may be superior to, or more cost effective than,\nRegeneron’s Products and Regeneron’s Product Candidates; the extent to\nwhich the results from the research and development programs conducted by\nRegeneron and/or its collaborators or licensees may be replicated in other\nstudies and/or lead to advancement of product candidates to clinical trials,\ntherapeutic applications, or regulatory approval; unanticipated expenses; the\ncosts of developing, producing, and selling products; the ability of Regeneron\nto meet any of its financial projections or guidance and changes to the\nassumptions underlying those projections or guidance; the potential for any\nlicense, collaboration, or supply agreement, including Regeneron’s\nagreements with Sanofi and Bayer (or their respective affiliated companies, as\napplicable), to be cancelled or terminated; the impact of public health\noutbreaks, epidemics, or pandemics on Regeneron's business; and risks\nassociated with litigation and other proceedings and government investigations\nrelating to the Company and/or its operations (including the pending civil\nproceedings initiated or joined by the U.S. Department of Justice and the U.S.\nAttorney's Office for the District of Massachusetts), risks associated with\nintellectual property of other parties and pending or future litigation\nrelating thereto (including without limitation the patent litigation and other\nrelated proceedings relating to EYLEA(®) (aflibercept) Injection), the\nultimate outcome of any such proceedings and investigations, and the impact\nany of the foregoing may have on Regeneron’s business, prospects, operating\nresults, and financial condition. A more complete description of these and\nother material risks can be found in Regeneron’s filings with the U.S.\nSecurities and Exchange Commission, including its Form 10-K for the year ended\nDecember 31, 2025 and its Form 10-Q for the quarterly period ended June 30,\n2026. Any forward-looking statements are made based on management’s current\nbeliefs and judgment, and the reader is cautioned not to rely on any\nforward-looking statements made by Regeneron. Regeneron does not undertake any\nobligation to update (publicly or otherwise) any forward-looking statement,\nincluding without limitation any financial projection or guidance, whether as\na result of new information, future events, or otherwise.\nRegeneron uses its media and investor relations website and social media\noutlets to publish important information about the Company, including\ninformation that may be deemed material to investors. Financial and other\ninformation about Regeneron is routinely posted and is accessible on\nRegeneron's media and investor relations website\n(https://investor.regeneron.com) and its LinkedIn page\n(https://www.linkedin.com/company/regeneron-pharmaceuticals).\n\n Contacts:                                                                                                                                                           \n                                                                                                                                                                     \n Media Relations  Mary Heather Tel: +1 914-847-8650 mary.heather@regeneron.com  Investor Relations Matthew Feeney Tel: +1 914-847-1004 matthew.feeney@regeneron.com  \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/add5ebc7-88c9-49dc-8834-abbb07c622d1)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbpVm3B-20261001","title":"Phase 2 COURAGE Trial Confirms Trevogrumab Prevents Lean Mass and Muscle Loss During GLP-1 Receptor Agonist-induced Weight Loss ","author":"Globe Newswire","ticker":"REGN","created":"2026-10-01T15:30:00.255Z","tickers":["REGN"],"exchange":"NASDAQ","article_body":"In a predefined MRI substudy, trevogrumab prevented 70% of muscle loss\nassociated with semaglutide treatment \n\nA pre-specified subgroup analysis found that patients meeting the low lean\nmass definition for sarcopenia had greater loss of lean mass with semaglutide,\nand more preservation with trevogrumab\n\nFindings were presented at the European Association for the Study of Diabetes\n(EASD) Annual Meeting and is in press with The Lancet\n\nTARRYTOWN, N.Y., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,\nInc. (NASDAQ: REGN) today announced new results from the Phase 2 COURAGE trial\nevaluating trevogrumab (anti-GDF8/anti-myostatin) for its potential to prevent\nlean mass and muscle loss during GLP-1 receptor agonist-induced weight loss in\npeople living with obesity. The results of the trial were presented during a\nScientific Symposium at the European Association for the Study of Diabetes\n(EASD) Annual Meeting and is in press with The Lancet. Building on these\npositive findings, Regeneron is planning to initiate a Phase 2 trial\nevaluating trevogrumab in combination with GLP-1 receptor agonist-based\ntherapies in older adults with obesity and decreased muscle mass and/or\nstrength.\n\n“COURAGE demonstrated that trevogrumab, which blocks myostatin, can preserve\nlean mass and muscle during semaglutide-induced weight loss,” said Julio\nRosenstock, M.D., Lead Principal Investigator of the COURAGE trial and\nClinical Professor of Medicine, University of Texas Southwestern Medical\nCenter, Dallas. “These results, sustained through a full year of treatment,\nwere further validated by MRI measurements of muscle volume supporting\ncontinued clinical development of trevogrumab and future research into muscle\npreservation as part of obesity care.”\n\nCOURAGE investigated the quality of weight loss in people living with obesity\n(BMI ≥30 kg/m(2)) in two independent portions over 52 weeks. A higher-dose\nportion evaluated trevogrumab (200 mg or 400 mg) in combination with\nsemaglutide 2.4 mg for 26 weeks compared to semaglutide alone, and then\ntrevogrumab compared to placebo alone for an additional 26 weeks after\nsemaglutide was discontinued. The trial also included a treatment arm with\nsemaglutide, trevogrumab and an Activin-A inhibitor for which the results were\npreviously presented\n(https://www.globenewswire.com/Tracker?data=C9zE6Pxj7lY1skXO5T_aAwAcLGQWemu2qWFlvpHkZciKYrJ6DZ9zEiRbWwuCEp-jyd3mD6hVopeeUnjC6ZrH2QYDZ8WwVwkJ7b_aT_XbXsrdua2DMZSBHEMNE0D22WQMkgRlo5T6TnwGJUKJApzNKb7bMnhsw6A-gte0iO-XR6_nmzFJSoiLPtTco1KfrpWTUskMYUqfyKAzQn-HQu_PH_sme7CdrA0CH96sG4MN8Lg=).\n\nA lower-dose portion evaluated trevogrumab (25 mg or 75 mg) in combination\nwith semaglutide 2.4 mg compared to semaglutide monotherapy for 52 weeks. The\nresults in this portion replicated the findings of the higher-dose portion,\nwith the greatest reduction in lean mass occurring during the period of most\nrapid weight loss that was observed in the first six months of treatment.\nWhile lower-dose trevogrumab did not meaningfully enhance the weight loss\nachieved with semaglutide alone, it preserved lean mass at both 26 and 52\nweeks (the primary endpoint), compared to placebo, as outlined in the table\nbelow:\n\n Percent change in lean mass from baseline as measured by DXA                                                                                               \n Arm                              26 weeks                                                     52 weeks                                                     \n Placebo + semaglutide            -6.7% (95% CI: -7.9 to -5.5)                                 -7.3% (95% CI: -8.8 to -5.8)                                 \n Trevogrumab 25 mg + semaglutide  -4.7% (95% CI: -5.5 to -3.9)  29.9% lean mass preservation*  -5.8% (95% CI: -6.8 to -4.7)  20.5% lean mass preservation*  \n Trevogrumab 75 mg + semaglutide  -3.3% (95% CI: -4.1 to -2.4)  50.7% lean mass preservation*  -4.2% (95% CI: -5.3 to -3.1)  42.5% lean mass preservation*  \n\n*Relative to placebo + semaglutide\n\nAmong participants with evaluable MRI data, lower dose trevogrumab preserved\nalmost 70% of the thigh muscle that would have been otherwise lost with\nsemaglutide treatment alone, as outlined in the table below:\n\n Absolute change from baseline in fat free muscle volume (mean ± standard error) as measured by MRI                     \n Arm                              26 weeks                                   52 weeks                                   \n Placebo + semaglutide            -0.88 ± 0.21                               -1.03 ± 0.22                               \n Trevogrumab 25 mg + semaglutide  -0.32 ± 0.14  63.6% muscle preservation*   -0.29 ± 0.12  71.8% muscle preservation*   \n Trevogrumab 75 mg + semaglutide  -0.24 ± 0.13  72.7% muscle preservation*   -0.32 ± 0.13  68.9% muscle preservation*   \n\n*Relative to placebo + semaglutide\n\nThe lower doses of trevogrumab were generally well tolerated, with 77% of\nparticipants experiencing at least one adverse event (AE), compared with 82%\nof those who were treated with placebo. The most common AEs occurring in\n≥10% of patients were nausea, constipation, diarrhea and vomiting.\n\nAlso presented at EASD was a pre-specified subgroup analysis of participants\nwith low lean mass (LLM) at baseline. Compared to patients without LLM at\nbaseline, these patients experienced a greater loss of lean mass with\nsemaglutide alone and numerically more preservation of lean mass in\ncombination with trevogrumab. LLM was defined using the imaging component of\nthe sarcopenia definition established by the Foundation for the National\nInstitutes of Health (appendicular lean mass relative to BMI, measured by\nDXA).\n\n“As GLP-1 receptor agonist-based medicines become foundational to obesity\ncare, it is becoming increasingly recognized that the associated muscle loss\nis an increasing concern – particularly for people with sarcopenia, older\nadults and others where frailty is a real concern,” said Boaz Hirshberg,\nM.D., Senior Vice President, Clinical Development, Internal Medicine,\nRegeneron. “Our COURAGE trial not only confirms this concern about muscle\nloss but also shows that trevogrumab can be part of the solution, addressing\nnot the quantity, but rather the quality, of weight loss. It’s an approach\nwe’re building across our growing pipeline.”\n\nAdditionally, Hansoh presented data from their Phase 3 trial in Chinese\npatients evaluating olatorepatide for the treatment of adults with obesity or\nwho are overweight. Olatorepatide is a novel GLP-1/GIP receptor agonist for\nwhich Regeneron has exclusive clinical development and commercial rights\noutside of the Chinese Mainland, Hong Kong and Macau as part of a\nstrategic in-licensing agreement.\n\nThe safety and efficacy of trevogrumab and olatorepatide have not been\nevaluated by any regulatory authority.\n\nAbout Regeneron in Obesity \nObesity is a complex, multifaceted disease and a growing public health\nconcern that affects more than a billion people worldwide. Despite the\nrevolutionary impact of GLP-1 receptor agonists (GLP-1RAs) on weight loss, the\nquality of this weight loss can be negatively impacted because these agents\ncan cause profound muscle loss. \nAt Regeneron, we are developing a pipeline focused on the quality of weight\nreduction. We have several independent approaches focused on promoting and\npreserving muscle during weight loss, so as to increase the amount of fat loss\nsince adiposity is the principal driver of comorbidities and metabolic\ndiseases associated with obesity. In addition, Regeneron has an extensive\npipeline of agents to address some of these co-morbidities and metabolic\ndiseases, which have the potential to be combined with GLP-1RAs. The\ncombination of our science, pipeline, research and clinical innovation\nuniquely positions us to make a meaningful difference in obesity and\nobesity-related diseases.  \n\nAbout Regeneron\nRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents,\ndevelops and commercializes life-transforming medicines for people with\nserious diseases. Founded and led by physician-scientists, our unique ability\nto repeatedly and consistently translate science into medicine has led to\nnumerous approved treatments and product candidates in development, most of\nwhich were homegrown in our laboratories. Our medicines and pipeline are\ndesigned to help patients with eye diseases, allergic and inflammatory\ndiseases, cancer, cardiovascular and metabolic diseases, neurological\ndiseases, hematologic conditions, infectious diseases, and rare diseases.\n\nRegeneron pushes the boundaries of scientific discovery and accelerates\ndrug development using our proprietary technologies, such\nas VelociSuite(®), which produces optimized fully human antibodies and new\nclasses of bispecific antibodies. We are shaping the next frontier of\nmedicine with data-powered insights from the Regeneron Genetics\nCenter(®) and pioneering genetic medicine platforms, enabling us to\nidentify innovative targets and complementary approaches to potentially treat\nor cure diseases.\nFor more information, please visit www.Regeneron.com or follow Regeneron on\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=gTyV7byn7joDZWD5iBWvnfKodMMsalS7cNl2z896cDrp4VELCMUi-B15mgyvXkRwaIWH4JUPC68fW8JM9BLAFEZJw80NxAnRj4mjcUa00MNKC5zuaEkXKeoaNiSwOPx48xFR7TiNqvkkaOhvKDQTVehoOlHXXS6TcbRAuy5guY065BKxubYzrXoqZ_9hbEUFWKrqgdXueIwTRfY2O72pZudnLxIWD8ij_i20D5R9iZvHgo2EHHT0tChJ6B-N-Uysvlx_ITIHx4an6amgiCXXQw==),\nInstagram\n(https://www.globenewswire.com/Tracker?data=T3vFTXJNkvzAMr4xM95V2PuHx4A1dEgorJg2oaDlvxwU-Vg80yUc2NgEim8ohxYO-_Pu1PdshU1KX0Ykvl6CNLSRPAtki7uD3EJU34dVO9TRJ3t46k5g9Zy9O9lLlSA3kq0foM9BO_iRce_dk2WPpQBQYEWKJ6vp38zQUQFR6XO6AVNgN4KFzisdbr3NEU0KdaDkdgG2FvdpRLzbJoOg_MzE2ITe43SJHSe5dQAFWIPNz7-YKr8pyLgP30Ww4uGT),\nFacebook\n(https://www.globenewswire.com/Tracker?data=kGk0lPV8cJzYZaxoJyB-S0AwJ8EoJsSJqPUOc5ESPJmbsuJBS-1zqLDoeMb_-GokY8b-hykFhh8Oouo03sNrZmVvCHGZTeOoG2tJO5x0FaxhaCO4gS-vqq2SpXznND05Rkyim3RvvVArDxMfnEuEbIxRmCPK4T38W-6dlBpRlj_u4fMif3tqEWmAPErvEuo-DfnN9z-PHEZb4IEO1yNtwOUzWc16CRHSfph1Z4TJq68auSapeRa-peXruegvXNFx)\nor X\n(https://www.globenewswire.com/Tracker?data=uv3T66n0Q1UYPuPAawzMWFfIaNXdRsxkjN29A1vAcbxscjmwLdiljd-Wvmlq1c7uEHeQKVTRq75qllbUyJUVhcbwTZgjHxU1bc0WJekXEKmy7YP0m44S-TmsGTN-dRJlFSTa7j4iLGoRz9R2ia68TMRxGXAFVa_lfcE7O-FriNjN3DFEHBci2RjOHVzzev-zNKR4YLgfjmE2igG3uvJHZA==).\n\nForward-Looking Statements and Use of Digital Media \nThis press release includes forward-looking statements that involve risks and\nuncertainties relating to future events and the future performance of\nRegeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and\nactual events or results may differ materially from these forward-looking\nstatements. Words such as “anticipate,” “expect,” “intend,”\n“plan,” “believe,” “seek,” “estimate,” variations of such\nwords, and similar expressions are intended to identify such forward-looking\nstatements, although not all forward-looking statements contain these\nidentifying words. These statements concern, and these risks and uncertainties\ninclude, among others, the nature, timing, and possible success and\ntherapeutic applications of products marketed or otherwise commercialized by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Products”) and product candidates being developed by\nRegeneron and/or its collaborators or licensees (collectively,\n“Regeneron’s Product Candidates”) and research and clinical programs now\nunderway or planned, including without limitation the clinical programs\ndiscussed or referenced in this press release evaluating trevogrumab\n(anti-GDF8/anti-myostatin) in combination with semaglutide or other GLP-1\nreceptor agonist-based therapies to prevent lean mass and muscle loss during\nGLP-1 receptor agonist-induced weight loss as well as olatorepatide as a\nmonotherapy for the treatment of adults with obesity or who are overweight;\nuncertainty of the utilization, market acceptance, and/or commercial success\nof Regeneron’s Products and Regeneron’s Product Candidates and the impact\nof studies (whether conducted by Regeneron or others and whether mandated or\nvoluntary), including the studies discussed or referenced in this press\nrelease, on any of the foregoing or any potential regulatory approval of\nRegeneron’s Products and Regeneron’s Product Candidates (such as those\nreferenced above); the likelihood, timing, and scope of possible regulatory\napproval and commercial launch of Regeneron’s Product Candidates and new\nindications for Regeneron’s Products, such as those referenced above; the\nability of Regeneron’s collaborators, licensees, suppliers, or other third\nparties (as applicable) to perform manufacturing, filling, finishing,\npackaging, labeling, distribution, and other steps related to Regeneron’s\nProducts and Regeneron’s Product Candidates; the ability of Regeneron to\nmanage supply chains for multiple products and product candidates and risks\nassociated with tariffs and other trade restrictions; safety issues resulting\nfrom the administration of Regeneron’s Products and Regeneron’s Product\nCandidates (such as those referenced above) in patients, including serious\ncomplications or side effects in connection with the use of Regeneron’s\nProducts and Regeneron’s Product Candidates in clinical trials;\ndeterminations by regulatory and administrative governmental authorities which\nmay delay or restrict Regeneron’s ability to continue to develop or\ncommercialize Regeneron’s Products and Regeneron’s Product Candidates;\nongoing regulatory obligations and oversight impacting Regeneron’s Products,\nresearch and clinical programs, and business, including those relating to\npatient privacy; the availability and extent of reimbursement or copay\nassistance for Regeneron’s Products from third-party payors and other third\nparties, including private payor healthcare and insurance programs, health\nmaintenance organizations, pharmacy benefit management companies, and\ngovernment programs such as Medicare and Medicaid; coverage and reimbursement\ndeterminations by such payors and other third parties and new policies and\nprocedures adopted by such payors and other third parties; changes to drug\npricing regulations and requirements and Regeneron’s pricing strategy,\nincluding in connection with Regeneron’s April 2026 agreements with the U.S.\ngovernment; other changes in laws, regulations, and policies affecting the\nhealthcare industry; competing products and product candidates (including\nbiosimilar products) that may be superior to, or more cost effective than,\nRegeneron’s Products and Regeneron’s Product Candidates; the extent to\nwhich the results from the research and development programs conducted by\nRegeneron and/or its collaborators or licensees may be replicated in other\nstudies and/or lead to advancement of product candidates to clinical trials,\ntherapeutic applications, or regulatory approval; unanticipated expenses; the\ncosts of developing, producing, and selling products; the ability of Regeneron\nto meet any of its financial projections or guidance and changes to the\nassumptions underlying those projections or guidance; the potential for any\nlicense, collaboration, or supply agreement, including Regeneron’s\nagreements with Sanofi and Bayer (or their respective affiliated companies, as\napplicable), to be cancelled or terminated; the impact of public health\noutbreaks, epidemics, or pandemics on Regeneron's business; and risks\nassociated with litigation and other proceedings and government investigations\nrelating to the Company and/or its operations (including the pending civil\nproceedings initiated or joined by the U.S. Department of Justice and the U.S.\nAttorney's Office for the District of Massachusetts), risks associated with\nintellectual property of other parties and pending or future litigation\nrelating thereto (including without limitation the patent litigation and other\nrelated proceedings relating to EYLEA(®) (aflibercept) Injection), the\nultimate outcome of any such proceedings and investigations, and the impact\nany of the foregoing may have on Regeneron’s business, prospects, operating\nresults, and financial condition. A more complete description of these and\nother material risks can be found in Regeneron’s filings with the U.S.\nSecurities and Exchange Commission, including its Form 10-K for the year ended\nDecember 31, 2025 and its Form 10-Q for the quarterly period ended June 30,\n2026. Any forward-looking statements are made based on management’s current\nbeliefs and judgment, and the reader is cautioned not to rely on any\nforward-looking statements made by Regeneron. Regeneron does not undertake any\nobligation to update (publicly or otherwise) any forward-looking statement,\nincluding without limitation any financial projection or guidance, whether as\na result of new information, future events, or otherwise.\nRegeneron uses its media and investor relations website and social media\noutlets to publish important information about the Company, including\ninformation that may be deemed material to investors. Financial and other\ninformation about Regeneron is routinely posted and is accessible on\nRegeneron's media and investor relations website\n(https://investor.regeneron.com) and its LinkedIn page\n(https://www.linkedin.com/company/regeneron-pharmaceuticals).\n\n Contacts:                                                                                                                                                           \n                                                                                                                                                                     \n Media Relations  Mary Heather Tel: +1 914-847-8650 mary.heather@regeneron.com  Investor Relations Matthew Feeney Tel: +1 914-847-1004 matthew.feeney@regeneron.com  \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/add5ebc7-88c9-49dc-8834-abbb07c622d1)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-01T15:30:00.339370818Z","server_sent_at_ms":1790868600339},"received_at":"2026-10-01T15:30:00.492Z","source_url":null},"analysis":{"id":"147196","press_release_id":"158570","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["trevogrumab and olatorepatide not yet evaluated by any regulatory authority","lower-dose trevogrumab did not meaningfully enhance weight loss vs semaglutide alone"],"eventType":"clinical_trial","narrative":"Regeneron announced Phase 2 COURAGE trial results showing trevogrumab, an anti-myostatin antibody, preserved lean mass during semaglutide-induced weight loss, with findings presented at EASD and accepted by The Lancet.\n\nAt the lower-dose portion, trevogrumab 75 mg plus semaglutide preserved 50.7% of lean mass at 26 weeks and 42.5% at 52 weeks versus placebo plus semaglutide; MRI substudy data showed roughly 70% of thigh muscle loss was prevented.\n\nRegeneron plans a new Phase 2 trial of trevogrumab with GLP-1 therapies in older adults with obesity and decreased muscle mass, extending its obesity pipeline beyond weight quantity to weight quality.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Muscle-preservation data positions Regeneron as a quality-of-weight-loss player alongside the GLP-1 boom."},"keyFigures":{"drugName":"trevogrumab (anti-GDF8/anti-myostatin)","phaseOfTrial":"Phase 2","customDimensions":{"trial_duration_weeks":52,"mri_muscle_preservation_up_to":"70%","lean_mass_preservation_75mg_26wk":"50.7%","lean_mass_preservation_75mg_52wk":"42.5%"}},"quotedText":"COURAGE demonstrated that trevogrumab, which blocks myostatin, can preserve lean mass and muscle during semaglutide-induced weight loss","namedEntities":{"people":[{"name":"Julio Rosenstock","role":"Lead Principal Investigator, COURAGE trial"},{"name":"Boaz Hirshberg","role":"Senior Vice President, Clinical Development, Internal Medicine, Regeneron"}],"products":["trevogrumab","semaglutide","olatorepatide","EYLEA (aflibercept)","VelociSuite"],"companies":[{"name":"Regeneron Pharmaceuticals, Inc.","ticker":"REGN"},{"name":"Hansoh","relationship":"partner"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive Phase 2 COURAGE data showing trevogrumab preserves lean mass during semaglutide-induced weight loss, in press with The Lancet and presented at EASD, with a new Phase 2 planned in older adults. Meaningful pipeline validation but not a binary regulatory or earnings event for a large-cap like Regeneron."},"tickerRelevance":{"others":[],"primary":"REGN"},"globalImportance":45,"audienceRelevance":60,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mega-cap biotech","eventGravity":"positive Phase 2 data in high-profile obesity franchise","householdBrandBoost":true,"marketCapAdjustment":"large diversified pipeline limits single-asset materiality","retailFavoriteBoost":"GLP-1/obesity theme attracts retail attention"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Regeneron announced Phase 2 COURAGE trial results showing trevogrumab, an anti-myostatin antibody, preserved lean mass during semaglutide-induced weight loss, with findings presented at EASD and accepted by The Lancet.\n\nAt the lower-dose portion, trevogrumab 75 mg plus semaglutide preserved 50.7% of lean mass at 26 weeks and 42.5% at 52 weeks versus placebo plus semaglutide; MRI substudy data showed roughly 70% of thigh muscle loss was prevented.\n\nRegeneron plans a new Phase 2 trial of trevogrumab with GLP-1 therapies in older adults with obesity and decreased muscle mass, extending its obesity pipeline beyond weight quantity to weight quality.","key_figures":{"drugName":"trevogrumab (anti-GDF8/anti-myostatin)","phaseOfTrial":"Phase 2","customDimensions":{"trial_duration_weeks":52,"mri_muscle_preservation_up_to":"70%","lean_mass_preservation_75mg_26wk":"50.7%","lean_mass_preservation_75mg_52wk":"42.5%"}},"named_entities":{"people":[{"name":"Julio Rosenstock","role":"Lead Principal Investigator, COURAGE trial"},{"name":"Boaz Hirshberg","role":"Senior Vice President, Clinical Development, Internal Medicine, Regeneron"}],"products":["trevogrumab","semaglutide","olatorepatide","EYLEA (aflibercept)","VelociSuite"],"companies":[{"name":"Regeneron Pharmaceuticals, Inc.","ticker":"REGN"},{"name":"Hansoh","relationship":"partner"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-01T15:30:06.547Z","global_importance":45,"audience_relevance":60,"importance_components":{"tickerTier":"mega-cap biotech","eventGravity":"positive Phase 2 data in high-profile obesity franchise","householdBrandBoost":true,"marketCapAdjustment":"large diversified pipeline limits single-asset materiality","retailFavoriteBoost":"GLP-1/obesity theme attracts retail attention"}},"durationMs":6035,"modelName":"glm-5.3-flashx"}}