Revita Hits Pivotal Endpoint, Cuts Post-GLP-1 Weight Regain by 53%
GUTS is trading near its 52-week low of $3.78 (12% above the low).
Summary
Fractyl's Revita met the six-month co-primary endpoint in the 308-patient REMAIN-1 pivotal study, with patients retaining 80% of GLP-1-induced weight loss versus 67% for sham (p=0.0023). In the complete-ablation subgroup (>=20 cm), weight regain was 3.8% versus 8.2% for sham, a 53% reduction. No device- or procedure-related serious adverse events were reported. A Category III CPT code 1122T for the Revita procedure takes effect January 1, 2027. The company plans a De Novo FDA submission in late Q4 2026, with 12-month data and the second co-primary endpoint due Q1 2027. This is the first pivotal randomized sham-controlled win for a procedural post-GLP-1 weight maintenance therapy, and it lands just two weeks after the 1-for-12 reverse split took effect to hold Nasdaq's $1.00 minimum bid. The company still carries a going concern warning and terminated its ATM in May, so the readout is the main near-term lever on both the stock and its financing options. Watch the 8:00 a.m. ET investor webcast today and the Q1 2027 one-year data.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — The 8-K confirms the REMAIN-1 six-month co-primary endpoint win (p=0.0023) and adds a Category III CPT code 1122T for the Revita procedure effective January 1, 2027.
At the time of this announcement, GUTS was trading at $4.24 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $55.2M. The 52-week trading range was $3.78 to $29.34. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.