Fractyl Health told investors in September 2025 that Revita-treated patients lost an additional 2.5% of body weight after stopping GLP-1 drugs; four months later the Company reported 4.5% weight regain, and GUTS shares closed at $0.46.

NEW YORK, Aug. 26, 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. Check if you might be eligible to recover your investment losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

GUTS shares fell $1.245, or 68.03%, to close at $0.585 on January 29, 2026, then declined another $0.125, or 21.37%, to $0.46 on January 30, 2026, a cumulative decline of roughly 74.86% from the $1.83 class-period reference price. The lead plaintiff deadline is October 20, 2026.

The Promise

On September 26, 2025, the Company reported three-month REMAIN-1 Midpoint Cohort data stating that Revita-treated patients “lost an additional 2.5% total body weight after stopping GLP-1 drugs vs. 10% regain in sham-treated patients.” The results were publicly characterized as “groundbreaking,” “clinically and statistically significant,” and “striking.” The same day, the Company priced a 60 million share offering at $1.00 per share.

The Reality

On January 29, 2026, six-month Midpoint Cohort data showed Revita-treated patients experienced 4.5% weight regain versus 7.5% in the sham arm. The complaint contends that operational problems at one of six study sites, described in analyst coverage as having a “relatively less robust diet and lifestyle counseling program” and not having “yet set up a dietary center,” affected the integrity of the reported efficacy data and were not disclosed to investors during the Class Period.

Promise vs. Actual: By the Numbers

• Promised (Sept. 2025): additional 2.5% total body weight lost after GLP-1 discontinuation. Actual (Jan. 2026): 4.5% weight regain.
• Promised sham-arm contrast: 10% regain. Actual sham-arm result: 7.5% regain.
• Offering proceeds raised during the Class Period: approximately $20.7 million in August 2025 and $56 million in September 2025, for roughly $76.7 million combined.
• Morgan Stanley price target: cut from $8.00 to $2.00; probability of success for Revita cut from 50% to 35%.
• Share price: $0.585 on January 29, 2026; $0.46 on January 30, 2026.

“Companies that make specific efficacy claims to investors have an obligation to disclose known problems affecting the data behind those claims. Here, the gap between the September 2025 figures and the January 2026 results is central to the complaint’s allegations.” — Joseph E. Levi, Esq.

What the Lawsuit Alleges About the Gap

The action asserts that Revita’s clinical, regulatory, and commercial prospects were overstated, and that the Midpoint Cohort’s ability to assess efficacy was likewise overstated, rendering the Company’s public statements materially false and misleading. The case is pending in the United States District Court for the Southern District of New York.

Learn more about the case or call (212) 363-7500.

Levi & Korsinsky, LLP — Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered.

Frequently Asked Questions About the GUTS Lawsuit

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 failed to disclose operational issues at a REMAIN-1 Midpoint Cohort study site that allegedly compromised the integrity of efficacy results. When six-month Midpoint Cohort data showing 4.5% weight regain and the “outlier site” issue were disclosed, the stock price declined sharply.

Q: How much did GUTS stock drop? A: Shares fell $1.245, or 68.03%, on January 29, 2026, then a further $0.125, or 21.37%, on January 30, 2026. Investors who purchased shares during the Class Period at artificially inflated prices 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 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: How long will the lawsuit take to resolve? A: Securities class actions typically take two to four years from initial filing to resolution. Timing depends on the court schedule, case developments, and whether the matter is dismissed, settled, or litigated further.

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