Revita Maintains 84% of Weight Loss After GLP-1 Cessation in Midpoint Trial
GUTS has more than doubled off its 52-week low of $0.377.
Summary
Fractyl Health's Revita procedure demonstrated durable weight maintenance one year after GLP-1 discontinuation in the REMAIN-1 Midpoint Cohort. In the optimized subgroup, Revita retained 84% of GLP-1-induced weight loss versus 46% with sham, with a 91% responder rate. No device-related serious adverse events occurred. This follows positive one-year Reveal-1 open-label data reported in June, but REMAIN-1 is a randomized controlled trial, strengthening the evidence for Revita's efficacy. The company plans to report six-month pivotal cohort data in early Q4 2026 and potentially submit a De Novo application to the FDA by late Q4 2026. With a market cap around $127 million and a going concern warning, positive pivotal data could be transformative for the company's prospects.
At the time of this announcement, GUTS was trading at $0.84 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $126.9M. The 52-week trading range was $0.38 to $2.45. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.