Fractyl Health, Inc. Class Action Lawsuit - GUTS
Case Summary
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The Fractyl Health class action lawsuit seeks to represent purchasers or acquirers of Fractyl Health, Inc. (NASDAQ: GUTS) securities between January 13, 2025 and January 29, 2026, inclusive (the “Class Period”). Captioned Lorne v. Fractyl Health, Inc., No. 26-cv-07167 (S.D.N.Y.), the Fractyl Health class action lawsuit charges Fractyl Health and certain of Fractyl Health’s top current and former executives with violations of the Securities Exchange Act of 1934.
If you suffered substantial losses and wish to serve as lead plaintiff of the Fractyl Health class action lawsuit, please provide your information in the form on this page. You can also contact attorneys Ken Dolitsky or Michael Albert of Robbins Geller by calling 800/851-7783 or via e-mail at info@rgrdlaw.com. Lead plaintiff motions for the Fractyl Health class action lawsuit must be filed with the court no later than October 20, 2026.
CASE ALLEGATIONS: Fractyl Health is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes (T2D) and obesity. Fractyl Health is allegedly developing, among other things, 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 were highly focused on advancing Revita through Fractyl Health’s “REMAIN-1” study, evaluating Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist drug therapy. The REMAIN-1 study is allegedly designed to include three distinct patient cohorts: (i) the REVEAL-1 Cohort; (ii) the REMAIN-1 Midpoint Cohort; and (iii) the REMAIN-1 Pivotal Cohort.
The Fractyl Health class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) 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; (ii) 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 (iii) as a result, defendants’ public statements were materially false and misleading at all relevant times.
On January 29, 2026, during pre-market hours, Fractyl Health issued a press release announcing six-month data from the REMAIN-1 Midpoint Cohort, allegedly disclosing 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 complaint alleges that Fractyl Health also hosted a conference call with investors and analysts that same day during pre-market hours. During the call, Fractyl Health’s Chief Executive Officer, Harith Rajagopalan, allegedly 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 Fractyl Health stock fell more than 68%, according to the complaint.
During post-market hours on January 29, 2026, Canaccord Genuity issued a report on Fractyl Health, allegedly providing additional color on the site-specific issue identified by Rajagopalan. According to the complaint, the Canaccord Genuity report cited a “call with mgmt [that] clarified some of the key FAQs around the ‘outlier site,’” stating that Fractyl Health “attribute[d] the variability in the 1 outlier site (out of 6) to a relatively less robust diet and lifestyle counseling program,” noting that “[t]his site was the first to enroll and hadn’t yet set up a dietary center.” Morgan Stanley also issued a report on Fractyl Health during post-market hours, allegedly downgrading Fractyl Health to an “Equal-weight” from “Overweight” rating and cutting its price target on Fractyl Health’s stock to $2.00 from $8.00. The Morgan Stanley report allegedly characterized the latest REMAIN-1 Midpoint Cohort study results as “[d]isappoint[ing],” noting that the “[r]andomized 6mo results for Revita in weight maintenance showed trends, but fell short of expectations, raising questions.” The complaint alleges that the Morgan Stanley report noted that “Revita patients experienced 4.5% weight regain (+1.5% in open label cohort) vs. 7.5% sham (~10% expected),” which “represents a 40% delta vs. sham, below the 50% threshold, suggesting more modest benefits, though was negatively impacted by a single site.” The Morgan Stanley report allegedly concluded that “[g]iven our more cautious view, we lower our probability of success for Revita to 35% from 50%, previously” and “now model peak risk-adjusted worldwide sales of ~$490M in 2035 (previously $700M).” On this news, the price of Fractyl Health stock fell more than 21% further, according to the complaint.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Fractyl Health securities during the Class Period to seek appointment as lead plaintiff in the Fractyl Health class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Fractyl Health class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Fractyl Health class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Fractyl Health class action lawsuit.
ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud and shareholder rights litigation. Our Firm ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report, recovering more than $916 million for investors in 2025. This marks our fourth #1 ranking in the past five years. And in those five years alone, Robbins Geller recovered $8.4 billion for investors – $3.4 billion more than any other law firm. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig.