Investing.com -- Fractyl Health (NASDAQ:GUTS) stock fell 35% after the company released six-month randomized midpoint data from its REMAIN-1 study evaluating Revita for weight maintenance following GLP-1 drug discontinuation.
The metabolic therapeutics company reported that Revita-treated patients experienced a 4.5% weight regain versus 7.5% in the sham arm at 6 months, showing an attenuation of expected post-GLP-1 rebound trajectory. An exploratory analysis of patients who achieved above median weight loss during GLP-1 run-in showed that Revita-treated participants experienced 4.2% weight regain versus 13.3% with sham.
Despite the company characterizing the results as positive, investors appeared to be disappointed with the data, sending shares sharply lower. The study was not designed to be sufficiently powered for efficacy analysis, according to the company.
Fractyl also reported that Revita-treated patients demonstrated improvements in cardiometabolic lipid parameters versus sham at 6 months, including increased HDL cholesterol and reduced triglyceride-to-HDL ratio. The company noted that patient-reported outcomes showed meaningful reductions in sweet-food craving versus sham.
The company said it has requested FDA feedback on reclassifying Revita under the De Novo pathway rather than a Premarket Approval, with feedback expected in Q2 2026. Fractyl anticipates releasing topline 6-month pivotal data and potentially filing with the FDA in the second half of 2026.
Fractyl is advancing toward multiple clinical and regulatory milestones across its REMAIN-1 weight maintenance program, with complete randomizations in the REMAIN-1 Pivotal Cohort expected in February 2026.
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