Fractyl Sinks ~48% Despite Positive Revita Trial Data as Lawsuit Fears Mount
GUTS is trading near its 52-week low of $2.02 (1.2% above the low) on elevated volume (34× avg).
Summary
Fractyl's Revita hit its six-month co-primary endpoint in the 308-patient REMAIN-1 study — patients kept about 80% of their GLP-1-driven weight loss versus 67% for sham, with least-squares mean regain of 5.1% vs 8.2% (p=0.0023) — yet the stock is down roughly 48% to about $2.18, near its 52-week low. The selloff is tied to a securities class action alleging the company overstated Revita's effectiveness and hid clinical site issues; the lead-plaintiff deadline is Oct. 20. Investors are comparing these numbers to the March post-hoc data, where a selected subgroup retained 88% of weight loss versus 60% for sham, making the broader topline look weaker by contrast. The company still plans a De Novo FDA submission in late Q4 2026, with a Category III CPT code effective Jan. 1, 2027, one-year Pivotal Cohort data in Q1 2027, and potential authorization in late 2027. This follows the Oct. 1 8-K finalizing the 1-for-12 reverse split and the September Nasdaq delisting notice — the equity is now trading near its post-split low with a going-concern overhang.
At the time of this announcement, GUTS was trading at $2.05 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $55.2M. The 52-week trading range was $2.02 to $29.34. This news item was assessed with negative market sentiment and an importance score of 7 out of 10. Source: Benzinga.