Business
Coya Therapeutics Announces FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the U.S. Food and Drug Administration ("FDA" or the "Agency") has accepted its Investigational New Drug (IND) application for COYA 302. This proprietary immunomodulatory biologic combination therapy is being developed for the treatment of patients with am
About this update from Coya Therapeutics, Inc.
[{"type":"text","content":"FDA acceptance enables initiation of a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS","length":176,"tagName":"p","attribs":{}},{"type":"text","content":"HOUSTON, Aug. 25, 2025 /PRNewswire/ -- Coya Therapeutics, Inc. (NASDAQ: COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the U.S. Food and Drug Administration ("FDA" or the "Agency") has accepted its Investigational New Drug (IND) application for COYA 302. This proprietary immunomodulatory biologic combination therapy is being developed for the treatment of patients with amyotrophic lateral sclerosis (ALS).","length":618,"tagName":"p"},{"type":"image","alt":"Coya Therapeutics Logo (PRNewsfoto/Coya Therapeutics, Inc.)","displaySize":"","headline":null,"caption":"Coya Therapeutics Logo (PRNewsfoto/Coya Therapeutics, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":166,"url":"https://media.zenfs.com/en/prnewswire.com/fb38d4ecdc4a3b01b49e80cb14dc14c0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/6YOAPSIXWRSkBXjtK9S80A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTI5MztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/fb38d4ecdc4a3b01b49e80cb14dc14c0","width":400,"height":166}},"href":"https://mma.prnewswire.com/media/2748215/Coya_Therapeutics_Transparent_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Arun Swaminathan, Chief Executive Officer, added: "The FDA's acceptance of this IND marks a pivotal moment in Coya's journey. We are now preparing to initiate a well-powered, well-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS. We are grateful to the ALS community for their continued support of this important program."","length":398,"tagName":"p"},{"type":"text","content":"Milan Kalawadia, Chief Executive Officer, North America, at Dr. Reddy's Laboratories Ltd. ("DRL") stated, "We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study. This milestone further reinforces...