Fractyl Health, Inc. (NASDAQ: GUTS)

This lawsuit is for anyone who acquired securities in Fractyl Health, Inc. (NASDAQ: GUTS) from January 13, 2025 through January 29, 2026.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by telling investors that the Company’s Revita DMR System, an outpatient procedural therapy designed to maintain weight loss following the discontinuation of GLP-1 receptor drug therapy, was more effective than the Company has a reasonable basis to believe.

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, the price of the Company’s stock dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Fractyl Health, Inc. (NASDAQ: GUTS) from January 13, 2025 through January 29, 2026 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.