Fractyl Health Says REMAIN-1 Meets Six-Month Co-Primary Endpoint
Fractyl Health said Revita showed a statistically significant reduction in weight regain versus sham (p=0.0023). The company plans a De Novo FDA submission for late Q4 2026 and expects 12-month data in Q1 2027.
Fractyl Health said REMAIN-1 met its six-month co-primary endpoint, with Revita showing a statistically significant reduction in weight regain vs sham (p=0.0023). A De Novo FDA submission is planned for late Q4 2026; 12-month data are expected in Q1 2027.Material DetailsContext by AI AnalystThis is…