Fractyl Health's Investment Narrative Takes Shape with Revita's Potential in Post-GLP-1 Weight Maintenance.

Fractyl Health reported positive 6-month randomized results from the REMAIN-1 Midpoint Cohort study of its Revita procedure for weight maintenance after GLP-1 drug discontinuation. The company is seeking FDA feedback on a potential De Novo regulatory pathway. A packed 2026 roadmap includes clinical readouts and regulatory milestones for Revita, potentially leading to a U.S. marketing submission. The encouraging data and De Novo discussions sharpen Fractyl Health's investment narrative, but the company's limited cash runway and ongoing losses remain concerns.