Fractyl Health: Revita met 6‑month co-primary endpoint, 80% GLP-1 weight loss retained vs 67% for sham

Fractyl Health (NASDAQ:GUTS) reported positive results from its REMAIN-1 study, showing participants who received the Revita DMR System maintained 80% of their weight loss compared to 67% for the sham group. The study involved 308 participants with obesity. The company plans to submit a De Novo marketing application to the FDA in late Q4 2026 and anticipates a U.S. commercial launch in early 2028, subject to FDA authorization.

FRACTYL HEALTH, INC. (GUTS) filed an SEC Form 8-K — Other Events. Exhibit 99.1 Fractyl Health's Revita Meets Six-Month Co-Primary Endpoint in Ongoing REMAIN-1 Pivotal Study, With Highly Statistically Significant Reduction in Weight Regain After GLP-1 Discontinuation REMAIN-1 met its six-month co-primary endpoint with high statistical significan

Fractyl Health (GUTS) reported positive six-month results from its REMAIN-1 study, showing that patients treated with its Revita DMR System maintained 80% of weight loss after stopping GLP-1 therapy, compared to 67% in the control group. The study met its primary endpoint with high statistical significance. Fractyl plans to submit a De Novo marketing application to the FDA in late 2026 and anticipates a potential U.S. launch in early 2028. The company will host a webcast to discuss the results.

Fractyl Health (GUTS) shares rose 2.8% pre-market ahead of a Virtual Commercial Strategy Day. The company will discuss its Revita therapy's commercial strategy and market opportunity, following positive REMAIN-1 clinical data. Analysts have differing ratings, with Bank of America issuing a 'Buy' and Morgan Stanley a 'Hold'. The company targets FDA application in late 2026.

Fractyl Health (GUTS) stock rose 2.8% in pre-market trading ahead of its Virtual Commercial Strategy Day, where management will discuss the commercial strategy for Revita, its procedural therapy. Recent clinical data showed patients maintained 84% of GLP-1-induced weight loss. Analysts from Bank of America and Morgan Stanley have differing ratings. The move is driven by company-specific catalysts, not broader market trends.

FRACTYL HEALTH, INC. (GUTS) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Fractyl Health Reports Second Quarter 2026 Financial Results and Business Updates One-year REMAIN-1 Midpoint Cohort data show Revita patients maintained up to 84% of prior GLP-1-induced weight loss versus 46% with sham in patients receiving complete duodenal ablation