GUTS Shareholder Alert: Fractyl Health, Inc. Securities Class Action Lawsuit - Investors Should Contact Levi & Korsinsky

A securities class action alleges Fractyl Health's SEC filings omitted disclosures required under Item 105 and Item 303 of Regulation S-K regarding operational problems at a REMAIN-1 clinical site, leaving investors with generic risk language while shares later fell 74.86%.

NEW YORK, Sept. 2, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Fractyl Health, Inc. (NASDAQ: GUTS) that a securities class action has been filed on behalf of shareholders who purchased securities between January 13, 2025 and January 29, 2026. Submit your information now. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.

GUTS shares fell from a Class Period high of $1.83 on January 28, 2026 to $0.46 on January 30, 2026, a cumulative decline of $1.37 per share, or 74.86%. The lead plaintiff deadline is October 20, 2026.

What Fractyl's SEC Filings Disclosed

Quarterly and annual reports filed during the Class Period described REMAIN-1 Midpoint Cohort results as "clinically and statistically significant" and reported that enrollment of all 45 participants had been completed, according to the complaint. SEC filings stated that the Midpoint Cohort "serves as an important early randomized readout" of Revita's potential.

What Plaintiffs Allege Was Missing

The complaint challenges those filings for omitting any discussion of operational conditions at one of the six Midpoint Cohort sites. Disclosure language indicated no site-level issues even as, the action contends, one site lacked a dietary center and ran a "relatively less robust diet and lifestyle counseling program" that allegedly produced "higher-than-expected regain across both arms."

Disclosure Gaps Alleged

• Item 105 of Regulation S-K allegedly required disclosure of material factors making an investment speculative or risky, including site-level conditions capable of distorting efficacy data.
• Item 303 allegedly required disclosure of known trends or uncertainties reasonably likely to have a material unfavorable impact.
• Sarbanes-Oxley certifications attached to the 2024 Form 10-K and the Q1, Q2, and Q3 2025 Forms 10-Q attested that filings omitted no material facts necessary to make statements not misleading.
• Registration materials supporting the August 2025 and September 2025 offerings, which together generated approximately $76.7 million in net proceeds, allegedly carried the same asserted omissions.
• Reported six-month results of 4.5% weight regain for Revita patients against 7.5% in the sham arm fell short of the 2.5% additional weight loss touted from three-month interim data.

"Generic risk factor language cannot substitute for disclosing specific, known problems that are already affecting a company's operations. The complaint alleges Fractyl's periodic filings described the Midpoint Cohort as a validating readout without addressing site conditions that allegedly compromised the data." -- Joseph E. Levi, Esq.

Find out if you might qualify to recover losses or call (212) 363-7500.

WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States.

Frequently Asked Questions About the GUTS Lawsuit

Q: What court was the GUTS class action filed in? A: The case was filed in the United States District Court for the Southern District of New York, governed by the Private Securities Litigation Reform Act of 1995.

Q: What specific misstatements does the GUTS lawsuit allege? A: The complaint alleges Fractyl Health, Inc. made materially false or misleading statements regarding the clinical efficacy of the Revita DMR System and omitted operational failures at a REMAIN-1 Midpoint Cohort study site during the Class Period. When the six-month Midpoint Cohort data and the outlier site issue were disclosed, the stock price declined sharply.

Q: Who is eligible to join the GUTS investor lawsuit? A: Investors who purchased GUTS stock or securities between January 13, 2025 and January 29, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses, not on whether you still hold the shares.

Q: What do GUTS investors need to do right now? A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. Submit your information for a no-cost, no-obligation evaluation of your potential recovery. No immediate action is required to remain eligible as an absent class member.

Q: What documents do I need to to submit my information? A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.

Q: What if I already sold my GUTS shares -- can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.

Q: What does it cost me to participate? A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in the securities class action, they are generally handled on a contingency basis, with any attorneys' fees and expenses subject to court approval.

Q: What if I live outside the United States? A: U.S. securities class actions generally cover purchases on U.S. exchanges regardless of the investor's country of residence.

CONTACT:\
Levi & Korsinsky, LLP\
Joseph E. Levi, Esq.\
Ed Korsinsky, Esq.\
33 Whitehall Street, 27th Floor\
New York, NY 10004\
[email protected]\
Tel: (212) 363-7500\
Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP