Robbins LLP is Investigating Allegations that Fractyl Health, Inc. Misled Investors Regarding the Viability and Efficacy of its Revita DMR System

Robbins LLP informs investors that a class action was filed on behalf of all persons and entities who purchased or otherwise acquired Fractyl Health, Inc. (NASDAQ: GUTS) securities between January 13, 205 and January 29, 2026 (the "Class Period"). Fractyl is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes (“T2D”) and obesity.

Why Was Fractyl Health Sued?

According to the complaint, Fracytl is developing, inter alia, the Revita DMR System (“Revita”), an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet.

The complaint alleges that during the Class Period, defendants failed to disclose that:

• Revita was less effective than defendants had led investors to believe, and/or operational issues at one or more of the REMAIN-1 Midpoint Cohort’s clinical sites compromised the integrity of its efficacy results;
• accordingly, Revita’s clinical, regulatory, and commercial prospects were overstated, as was the REMAIN-1 Midpoint Cohort’s ability to assess Revita’s efficacy; and
• as a result, defendants’ public statements were materially false and misleading at all relevant times.

Why Did Fractyl Health's Stock Drop?

Plaintiff alleges that on January 29, 2026, during pre-market hours, 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 CEO defendant Harith 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.

Following these disclosures, Fractyl’s stock price fell $1.245 per share, or 68.03%, to close at $0.585 per share on January 29, 2026.

On the same day, during post-market hours Morgan Stanely downgraded the stock to an "Equal-weight" from "Overweight" rating and cut its target price on the Company's stock to $2.00 from $8.00.

On this news, Fractyl Health's stock fell another 21.7%, to close at $0.46 per share on January 30, 2026.

Who May Be Eligible to Participate in the Fractyl Class Action?

The lawsuit seeks to represent investors who purchased or otherwise acquired Fractyl Health, Inc. common stock between January 13, 205 and January 29, 2026. Investors who suffered losses during that period may have legal rights under the federal securities laws. Submit a form for information.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.