Fractyl Health Completes REMAIN-1 Randomization After Positive Dose-Dependent Revita Results
Fractyl completed randomization in the REMAIN-1 Pivotal Cohort, received FDA feedback to support a De Novo submission, and expects six-month topline data in early Q4 2026. Post-hoc analyses of 45 patients show a dose-dependent effect: >14cm ablation retains 88% of GLP-1-induced weight loss versus 60% in sham at six months.
1. Q4 2025 Financial Results and Runway
Fractyl Health reported fourth-quarter and full-year 2025 results and reiterated cash runway guidance into early 2027, exceeding the anticipated pivotal data readout and supporting ongoing development of Revita.
2. REMAIN-1 Pivotal Cohort Progress
The company completed randomization in its REMAIN-1 Pivotal Cohort, marking a critical milestone ahead of the anticipated six-month topline readout in early Q4 2026 and positioning Revita for potential De Novo classification.
3. Post-Hoc Midpoint Cohort Analyses
New analyses from 45 midpoint patients demonstrate a statistically significant, dose-dependent treatment effect: participants receiving over 14 cm duodenal ablation retained 88% of GLP-1-induced weight loss at six months, compared with 60% for sham.
4. Regulatory Pathway and Next Steps
Following favorable FDA feedback, Fractyl plans to submit a De Novo classification request in late Q4 2026 and will host a conference call to discuss data, regulatory strategy, and commercialization planning.