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Fractyl's Revita shows significant weight regain reduction post-GLP-1 in REMAIN-1 study, advancing FDA submission plans.

Company Fundamentals
16 Oct 2026
GlobeNewsWire
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Bullish
Fractyl's Revita shows significant weight regain reduction post-GLP-1 in REMAIN-1 study, advancing FDA submission plans.

Fractyl Health's Revita DMR System met its six-month co-primary endpoint in the REMAIN-1 pivotal study, showing an 80% retention of GLP-1 induced weight loss compared to 67% for the sham group, with a statistically significant reduction in weight regain (p=0.0023). The study involved 308 adults with obesity who discontinued GLP-1 therapy, and Revita demonstrated safety with no serious adverse events. The company plans to submit a De Novo marketing application to the FDA in late Q4 2026, with topline one-year data expected in Q1 2027 and a potential U.S. launch in early 2028. This marks a potential new procedural therapy for maintaining weight loss after GLP-1 treatment.

Fractyl Health's Revita study results are presented here with Pluang's Health-sector market data as of Oct 16, 2026 17:01 WIB: Of 150 priced Health-sector US stocks tradable on Pluang, 91 rose and 44 fell today. Notable movers include HIMS at USD 28.98 with a 1-day change of -1.38% and Pluang order activity showing 35% Sell / 65% Buy, MMED at USD 18.24 with a 1-day change of +1.33%, and NUWE at USD 0.56 with a 1-day change of +1.23%. The typical hold time on Pluang ranges from 7 to 27 days among these stocks.

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