The Law Offices of Frank R. Cruz announces an investigation of Fractyl Health, Inc. (“Fractyl” or the “Company”) (NASDAQ: GUTS) on behalf of investors concerning the Company’s possible violations of federal securities laws.

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What Is The Investigation About?

On January 29, 2026, 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 Chief Executive Officer 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.

On this news, Fractyl's stock price fell $1.25 per share, or 68.04%, to close at $0.58 per share on January 29, 2026, thereby injuring investors.

Contact Us To Participate or Learn More:

If you purchased Fractyl Health, Inc. securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us:

The Law Offices of Frank R. Cruz,
2121 Avenue of the Stars, Suite 800,
Century City, California 90067
Call us at: 310-914-5007
Email us at: info@frankcruzlaw.com
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