REMAIN-1 Pivotal Cohort met its six-month co-primary endpoint with high statistical significance (p=0.0023); Revita ® participants retained approximately 80% of GLP-1-induced weight loss versus 67% for sham Planned FDA De Novo submission in late Q4 2026; topline 12-month data from the REMAIN-1 Pivotal Cohort anticipated in Q1 2027 Sharpened focus on Revita, with a workforce reduction of approxi...
BURLINGTON, Mass., Oct. 30, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced additions to its U.S. patent portfolio that strengthen the intellectual property foundation for investigational Revita® as the Company ...
Company estimates approximately one million U.S. patients each month discontinue GLP-1 medications and face the risk of weight regain One-third of surveyed GLP-1 users expressed a preference for an endoscopic procedure over continued GLP-1 medication A one-time procedure and freedom from daily or weekly medication were the most frequently selected positive attributes, supporting commercial plan...
Following positive topline six-month REMAIN-1 pivotal results, Revita advancing toward planned FDA De Novo submission in late Q4 2026 and anticipated 12-month pivotal data readout in Q1 2027 Workforce reduction aligns organization behind Revita's near-term clinical and commercial opportunity Company discontinuing development of Rejuva candidates and seeking strategic alternatives to maximize th...
REMAIN-1 met its six-month co-primary endpoint with high statistical significance (p=0.0023; mITT population); demonstrated 80% retention of GLP-1 induced weight loss vs 67% for sham
BURLINGTON, Mass., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced that it will host a virtual Commercial Strategy Day on Tuesday, September 1, 2026 at 11:00 AM ET to discuss the potential commercial op...
BURLINGTON, Mass., July 22, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will be participating in the following upc...
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