NEW YORK, Aug. 24, 2026 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of all persons or entities who purchased or otherwise acquired Fractyl Health, Inc. (“Fractyl” or the “Company”) (NASDAQ: GUTS) securities between January 13, 2025 through January 29, 2026,, inclusive (the “Class Period”).
The Complaint alleges that Fractyl is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes (“T2D”) and obesity. The Complaint also alleges the Company is developing the Revita DMR System (“Revita”) as an outpatient procedural therapy designed to durably modify duodenal dysfunction, a pathologic consequence of a high fat and high sugar diet.
In addition, the Complaint alleges that during the Class Period, Defendants were highly focused on advancing Revita through Fractyl’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 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 Complaint further alleges that at all relevant times, Defendants touted Revita’s efficacy as observed in interim data readouts from the REVEAL-1 and REMAIN-1 Midpoint Cohorts, while highlighting data from prior studies that likewise evaluated Revita’s ability to reduce weight gain under other circumstances. Defendants variously characterized such data as “groundbreaking”, “clinically and statistically significant”, and “striking”, while highlighting the purported “[c]lear evidence of Revita activity”.1 (Emphasis in original.)
Additionally, the Complaint alleges that in August and September 2025, on days coinciding with the release of positive data readouts purportedly demonstrating Revita’s efficacy potential, Defendants announced public offerings of Fractyl securities, receiving tens of millions of dollars in proceeds, allegedly riding on the hype generated by these purportedly promising results.
The Complaint further alleges that Defendants made false and misleading statements and/or failed to disclose material adverse facts, including allegations 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; and (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.
In addition, the Complaint alleges that the truth began to emerge on January 29, 2026, when, 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[.]”
Further, the Complaint alleges that 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 (“CEO”) 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.
Last, the Complaint alleges that 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.
Investors who purchased or otherwise acquired shares of GUTS should contact the Firm prior to the October 20, 2026 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
Please visit our website at http://www.gme-law.com for more information about the firm.
