Business
Fractyl Health Reports Fourth Quarter and Full Year 2025 Financial Results and Business Updates
Completed randomization in REMAIN-1 Pivotal Cohort; topline 6-Month data expected in early Q4 2026 Received favorable FDA feedback on De Novo classification
About this update from Fractyl Health, Inc.
[{"type":"text","content":"Completed randomization in REMAIN-1 Pivotal Cohort; topline 6-Month data expected in early Q4 2026 Received favorable FDA feedback on De Novo classification request; De Novo submission expected in late Q4 2026 Reports new post-hoc analyses from REMAIN-1 Midpoint Cohort showing statistically significant ablation-length (i.e., dose)-dependent treatment effect on post-GLP-1 weight maintenance at 6 months Patients with greater GLP-1-induced weight loss prior to randomization also exhibited larger sham-adjusted treatment effects at 6 months, with effect size increasing over time New analyses provide further support for Revita mechanism of action and REMAIN-1 Pivotal Cohort design Reiterates cash runway guidance into early 2027, beyond anticipated Pivotal data readout Conference call today at 4:30 p.m. ET BURLINGTON, Mass., March 24, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced fourth quarter and full year 2025 financial results and provided business updates. The Company also reported new post-hoc analyses from the REMAIN-1 Midpoint Cohort showing a statistically significant ablation length (i.e., dose)-dependent treatment effect on post GLP-1 weight maintenance at 6 months that further strengthens the Company's belief in the REMAIN-1 Pivotal Cohort, with topline 6-month randomized data expected in early Q4 2026 and, if positive, potential De Novo marketing application submission expected in late Q4 2026. “Completion of randomization in the REMAIN-1 Midpoint and Pivotal Cohorts marks a critical execution milestone, and today's new analyses from the Midpoint Cohort 6-month data gives us even greater anticipation for what the pivotal study might show. Revita® is a procedural therapy that appears to work very much like a drug: the effect of weight maintenance is larger in patients with greater GLP-1 weight loss and in those who receive longer lengths of duodenal ablation. The REMAIN-1 Pivotal Cohort was prospectively designed and statistically powered to demonstrate Revita's effect across these dimensions,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. “Approximately 30 million patients are projected to...