Fractyl Health reported six-month randomized midpoint data from REMAIN-1, its study of Revita aimed at supporting weight maintenance after patients stop GLP-1 therapy, and the market responded sharply: the company's stock fell about 35% on the news.
The data showed that patients who received Revita experienced a 4.5% average weight regain at six months compared with a 7.5% regain in the sham control arm, indicating an attenuation of the typical post-GLP-1 rebound trajectory. In a predefined exploratory subgroup of patients who achieved greater-than-median weight loss during the GLP-1 run-in period, Revita-treated participants averaged a 4.2% regain versus 13.3% with sham.
Fractyl characterized these findings as positive, noting both the overall and exploratory subgroup trends. However, investors appeared to interpret the midpoint readout differently and sold shares aggressively. The company emphasized that the study was not designed or sufficiently powered to support a conclusive efficacy analysis, a point that may have tempered market expectations.
Beyond weight outcomes, Fractyl reported favorable shifts in cardiometabolic lipid measurements among Revita-treated patients relative to sham at six months. The company specifically cited increases in HDL cholesterol and reductions in the triglyceride-to-HDL ratio. Patient-reported measures also favored Revita, with the company stating meaningful reductions in cravings for sweet foods compared with sham.
On the regulatory front, Fractyl said it has asked the U.S. Food and Drug Administration for feedback on seeking authorization for Revita through the De Novo pathway rather than pursuing a Premarket Approval filing. The company expects to receive FDA feedback in the second quarter of 2026. Fractyl also signaled plans to release topline six-month pivotal data and to potentially submit a regulatory filing in the second half of 2026.
Operationally, Fractyl continues to progress its REMAIN-1 weight maintenance program. The company noted that complete randomizations in the REMAIN-1 Pivotal Cohort are expected to be achieved in February 2026, a milestone that will feed into the pivotal dataset referenced for later in the year.
This report focuses strictly on the results and program milestones Fractyl disclosed and does not infer outcomes beyond the information the company provided.