Law Offices of Howard G. Smith reminds investors of the upcoming October 20, 2026 deadline to file a lead plaintiff motion in the case filed on behalf of investors who purchased Fractyl Health, Inc. (“Fractyl” or the “Company”) (NASDAQ: GUTS) securities between January 13, 2025 and January 29, 2026, inclusive (the “Class Period”).

IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN FRACTYL HEALTH, INC. (GUTS), CONTACT THE LAW OFFICES OF HOWARD G. SMITH TO PARTICIPATE IN THE ONGOING SECURITIES FRAUD LAWSUIT.

Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@howardsmithlaw.com, by telephone at (215) 638-4847 or visit our website at www.howardsmithlaw.com.

What Happened?

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.

What Is The Lawsuit About?

The complaint filed in this class action alleges that between January 13, 2025 and January 29, 2026, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors 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.

If you purchased or otherwise acquired Fractyl Health, Inc. securities between January 13, 2025 and January 29, 2026, you may move the Court no later than October 20, 2026 to ask the Court to appoint you as lead plaintiff if you meet certain legal requirements.

Contact Us To Participate or Learn More:
If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us:
Law Offices of Howard G. Smith,
3070 Bristol Pike, Suite 112,
Bensalem, Pennsylvania 19020,
Telephone: (215) 638-4847
Email: howardsmith@howardsmithlaw.com,
Visit our website at: www.howardsmithlaw.com.

To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260901046285/en/