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 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 ...