Shareholder rights law firm 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, 2025 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.

The complaint alleges that Fractyl Health misled investors regarding the viability and efficacy of its Revita DMR System.

Investors who suffered significant losses during the Class Period may be eligible to participate in the lawsuit and should contact Robbins LLP for information.

Why Was Fractyl Health Sued?

According to the complaint, Fractyl 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:

  1. 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;
  2. 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
  3. 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 Stanley 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 Can Participate in the Fractyl Health Class Action?

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 that period may have legal rights under the federal securities laws.

What Is a Lead Plaintiff?

The lead plaintiff is a court-appointed investor who represents the interests of all class members throughout the litigation. Serving as lead plaintiff is not required to share in any potential recovery. Investors who do not seek appointment may remain absent class members if the case proceeds and later resolves successfully.

Shareholders who wish to lead the case should contact Robbins LLP.

Does it cost anything to participate?

No. Robbins LLP represents investors on a contingency fee basis. Fees and litigation expenses are paid by defendants only if there is a recovery.

Contact Robbins LLP

Investors seeking additional information about the Fractyl Health Inc. securities class action may contact Robbins LLP by submitting an inquiry, emailing attorney Aaron Dumas, Jr., or calling (800) 350-6003.

About Robbins LLP

Robbins LLP is a shareholder rights law firm focused on representing investors in securities fraud and shareholder litigation. The firm has helped recover more than $1 billion for investors, obtained significant corporate governance reforms, and has represented shareholders in cases involving alleged violations of the federal securities laws.

“Companies have an obligation to provide investors with complete and accurate information so that markets can function fairly and efficiently,” said Brian J. Robbins, Founding Partner of Robbins LLP.

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