The Law Offices of Frank R. Cruz announces an investigation of Fractyl Health, Inc. (“Fractyl” or the “Company”) (NASDAQ: GUTS) on behalf of investors concerning the Company’s possible violations of federal securities laws.

On January 29, 2026, Fractyl issued a press release announcing six-month data from the REMAIN-1 Midpoint Cohort. The press release disclosed, in relevant part, that “[a]cross the prespecified efficacy population . . . , Revita-treated patients experienced a 4.5% weight regain vs 7.5% in the sham arm at 6 months”, representing a significantly more modest efficacy result than previously disclosed results and falling short of investor expectations, while stating that “[t]he Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis[.]”

The same day, also during pre-market hours, Fractyl hosted a conference call with investors and analysts to discuss the six-month data from the REMAIN-1 Midpoint Cohort. During the call, Fractyl’s Chief Executive Officer Defendant Harith Rajagopalan (“Rajagopalan”) indicated that issues at one of the REMAIN-1 Midpoint Cohort study sites, which “had higher-than-expected regain across both arms,” were at least partly to blame for the cohort’s disappointing six-month efficacy results.

On this news, Fractyl’s stock price fell $1.25 per share, or 68.04%, to close at $0.58 per share on January 29, 2026, thereby injuring investors.