Fractyl Health (NASDAQ:GUTS) shares plunged around 35% after the company released six-month randomized midpoint data from its REMAIN-1 trial studying Revita as a weight-maintenance therapy following discontinuation of GLP-1 drugs.
The company said patients treated with Revita regained 4.5% of body weight at six months, compared with 7.5% in the sham group, suggesting some moderation of the typical rebound seen after stopping GLP-1 therapy. In an exploratory subgroup of patients who achieved above-median weight loss during the GLP-1 run-in phase, Revita recipients recorded 4.2% weight regain versus 13.3% in the sham arm.
While Fractyl described the findings as encouraging, the market reaction was sharply negative. The company emphasized that the study was not designed or powered to formally assess efficacy, which may have tempered investor confidence.
Beyond weight outcomes, Fractyl reported that Revita-treated patients showed improvements in several cardiometabolic markers at six months, including higher HDL cholesterol and a lower triglyceride-to-HDL ratio. Patient-reported outcomes also indicated a meaningful reduction in sweet-food cravings compared with sham treatment.
On the regulatory front, Fractyl said it has asked the U.S. Food and Drug Administration for guidance on pursuing a De Novo classification for Revita rather than a Premarket Approval route, with feedback expected in the second quarter of 2026. The company plans to release topline six-month pivotal data and potentially submit a regulatory filing in the second half of 2026.
Fractyl added that it continues to progress toward multiple clinical and regulatory milestones within its REMAIN-1 weight-maintenance program, with full randomization of the pivotal cohort expected to be completed in February 2026.