Robbins LLP Files Class Action Against Fractyl Health Over Revita DMR System Claims

SAN DIEGO, Sept. 10, 2026 /CourierPR/ -- Robbins LLP, a law firm specializing in shareholder rights, has announced the filing of a class action lawsuit against Fractyl Health, Inc. (NASDAQ: GUTS), a metabolic therapeutics company focusing on therapies for type 2 diabetes and obesity. The lawsuit alleges that Fractyl Health misled investors regarding the viability and efficacy of its Revita DMR System.

According to the complaint, Fractyl Health is developing the Revita DMR System, an outpatient procedural therapy aimed at durably modifying duodenal dysfunction, which is a consequence of a high-fat and high-sugar diet. The complaint asserts that during the Class Period, which ran from January 13, 2025, to January 29, 2026, the company failed to disclose several critical issues. Specifically, the complaint claims that Revita was less effective than the company had led investors to believe, and operational issues at one or more of the REMAIN-1 Midpoint Cohort's clinical sites compromised the integrity of its efficacy results. As a result, the company's public statements were deemed materially false and misleading.

On January 29, 2026, during pre-market hours, Fractyl Health issued a press release announcing six-month data from the REMAIN-1 Midpoint Cohort. The press release disclosed that across the prespecified efficacy population, Revita-treated patients experienced a 4.5% weight regain compared to a 7.5% regain in the sham arm at 6 months. This result was significantly less effective than previously disclosed and fell short of investor expectations. Additionally, the press release noted that the Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis. During the same day, Fractyl Health hosted a conference call with investors and analysts, where CEO 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 responsible for the cohort's disappointing six-month efficacy results.

Following these disclosures, Fractyl Health's stock price plummeted by 68.03%, falling from $1.85 to $0.585 per share. On the same day, Morgan Stanley downgraded the stock to an "Equal-weight" rating from "Overweight" and cut its target price on the company's stock to $2.00 from $8.00. This led to an additional 21.7% drop in the stock price, closing at $0.46 per share on January 30, 2026.

The lawsuit seeks to represent investors who purchased or otherwise acquired Fractyl Health common stock between January 13, 2025, and January 29, 2026. Investors who suffered losses during this period may have legal rights under the federal securities laws. The lead plaintiff, a court-appointed investor who represents the interests of all class members throughout the litigation, is to be contacted by Robbins LLP before October 20, 2026. Robbins LLP represents investors on a contingency fee basis.

Investors seeking additional information about the Fractyl Health Inc. securities class action may contact Robbins LLP by submitting an inquiry or calling the firm at (800) 350-6003.