A securities class action has been filed against Fractyl Health, Inc. (“Fractyl” or the “Company”) and certain of its officers on behalf of persons and entities, other than Defendants, that purchased or otherwise acquired Fractyl securities between January 13, 2025 and January 29, 2026, both dates inclusive (the “Class Period”).

Fractyl common stock trades on the Nasdaq Global Market under the ticker symbol GUTS.

According to the complaint, Fractyl is a metabolic therapeutics company that develops therapies for the treatment of type 2 diabetes and obesity and is developing, among other things, the Revita DMR System (“Revita”).

What Does the Fractyl Health Securities Class Action Allege?

The action, Lorne v. Fractyl Health, Inc., et al., Case No. 1:26-cv-07167, was filed on August 21, 2026, in the United States District Court for the Southern District of New York. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 promulgated thereunder.

According to the complaint, during the Class Period Defendants made materially false and misleading statements and/or 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 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.

The complaint further alleges that Fractyl touted Revita’s efficacy based on interim data from the REVEAL-1 and REMAIN-1 Midpoint Cohorts. In September 2025, Fractyl announced three-month REMAIN-1 Midpoint Cohort data and characterized the results as “groundbreaking,” “clinically and statistically significant,” and “striking,” while highlighting purported “clear evidence of Revita activity.”

What Happened to Fractyl’s Stock Price?

The complaint alleges that the truth began to emerge on January 29, 2026, when Fractyl announced six-month data from the REMAIN-1 Midpoint Cohort. Fractyl reported that Revita-treated patients experienced 4.5% weight regain versus 7.5% in the sham arm at six months, which the complaint alleges represented a significantly more modest efficacy result than previously disclosed results and fell short of investor expectations. Fractyl also stated that the Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis.

According to the complaint, during an investor and analyst call that day, Fractyl CEO Harith Rajagopalan indicated that issues at one REMAIN-1 Midpoint Cohort study site, which had higher-than-expected regain across both arms, were at least partly responsible for the 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.

The complaint further alleges that, following the release of Canaccord Genuity and Morgan Stanley reports addressing the site-specific issue and the six-month results, Fractyl’s stock price fell an additional $0.125 per share, or 21.37%, to close at $0.46 per share on January 30, 2026.

Review the Fractyl Health securities class action complaint.

Fractyl Investors Who Suffered Losses

Investors who purchased or otherwise acquired Fractyl securities during the Class Period and suffered losses may complete Kehoe Law Firm’s confidential Stockholder Information Request Form or contact Michael Yarnoff, Esq. for a free, no-obligation evaluation of potential legal claims.

GUTS investors who wish to seek appointment as lead plaintiff have until October 20, 2026 to move the Court. An investor’s ability to share in any potential recovery does not depend on serving as lead plaintiff.

Michael Yarnoff, Esq.
(215) 792-6676, Ext. 804
[email protected]
[email protected]

About Kehoe Law Firm, P.C.

Kehoe Law Firm, P.C. is a nationally recognized, plaintiff-side class action law firm representing investors and consumers in matters involving securities fraud, corporate misconduct, mergers and acquisitions, antitrust violations, whistleblower claims, data breaches, consumer fraud, employment law violations, and retirement-plan mismanagement. Its attorneys have served as lead or co-lead counsel in major securities cases, recovering more than $10 billion for institutional and individual investors.

There is no cost or obligation to speak with the firm, and there are no upfront fees or litigation costs. We handle class action matters on a contingency-fee basis. Any attorneys’ fees or expenses sought in connection with a recovery are subject to court approval.

PHONE

Tel: 215-792-6676

EMAIL

[email protected]