Investors allege Fractyl Health overstated the clinical efficacy of its Revita DMR System while operational failures at a key REMAIN-1 study site compromised the integrity of weight maintenance data.

NEW YORK, Sept. 23, 2026 /PRNewswire/ — Levi & Korsinsky, LLP notifies investors in Fractyl Health, Inc. (NASDAQ: GUTS) that a class action lawsuit has been filed on behalf of shareholders who purchased securities between January 13, 2025 and January 29, 2026. Find out if you could qualify to recover your losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

GUTS shares fell approximately 74.86% across January 29 and January 30, 2026, a cumulative decline of roughly $1.37 per share from a class period close of $1.83 to $0.46. Applications to serve as lead plaintiff must be filed by October 20, 2026.

The Alleged Clinical Efficacy Overstatement

Revita was positioned as a one-time endoscopic therapy capable of sustaining weight loss after patients discontinue GLP-1 drugs, a market the Company described as a $175 billion opportunity. Interim readouts in September 2025 reported that Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 therapy, results the Company characterized as “groundbreaking” and “striking.” According to the lawsuit, those characterizations did not reflect known problems affecting the underlying study.

How Study Site Conditions Allegedly Affected Reported Results

On January 29, 2026, the Company reported six-month REMAIN-1 Midpoint Cohort data showing 4.5% weight regain in Revita-treated patients versus 7.5% in the sham arm, well short of expectations. The complaint alleges that one of six study sites had a relatively less robust diet and lifestyle counseling program and had not yet established a dietary center, producing higher-than-expected regain across both arms. The lawsuit contends that this operational condition was not disclosed to investors while the Company was promoting the cohort as an early validation of its pivotal study design.

Key Clinical Data Allegations for Shareholders

• Investors allege they were told the Midpoint Cohort profile closely mirrored the open-label REVEAL-1 Cohort, supporting expectations of comparable efficacy.
• The complaint alleges the Company omitted disclosure of site-level operational conditions that could skew the cohort’s efficacy readout.
• Six-month results allegedly reversed the prior narrative, showing regain rather than continued weight loss in the treated arm.
• The lawsuit contends risk disclosures under Item 105 of Regulation S-K omitted material factors making an investment speculative or risky.
• The complaint alleges the Company raised approximately $20.7 million in August 2025 and approximately $56 million in September 2025 while these conditions remained undisclosed.

“This case presents important questions about clinical data disclosure obligations in the medical device sector, including whether investors were told how site-level study conditions could affect reported efficacy,” said Joseph E. Levi, Esq. “Shareholders who purchased during the class period may wish to review their options.”

Submit your information here 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 is the GUTS class action lawsuit about? A: A securities class action has been filed against Fractyl Health, Inc. alleging materially false and misleading statements between January 13, 2025 and January 29, 2026. Shares fell approximately 74.86% on January 29, 2026 after the Company disclosed six-month REMAIN-1 Midpoint Cohort data showing 4.5% weight regain in Revita-treated patients and acknowledged an outlier study site with higher-than-expected regain. Investors who purchased shares during the Class Period and suffered losses may be eligible to seek compensation.

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 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 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 is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.

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

jlevi@levikorsinsky.com

Tel: (212) 363-7500

Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP