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

Pension funds, asset managers, and other fiduciaries holding Fractyl Health (NASDAQ: GUTS) during the Class Period may wish to evaluate lead plaintiff options in a securities class action alleging the Company overstated Revita DMR efficacy data while operational failures at a clinical study site allegedly went undisclosed.

NEW YORK, Sept. 16, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP notifies institutional 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. Request an institutional investor loss assessment. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.

GUTS shares declined a cumulative 74.86%, falling $1.37 from a January 28, 2026 close of $1.83 to $0.46 on January 30, 2026. Funds that participated in the August and September 2025 public offerings, which generated approximately $76.7 million in net proceeds, may hold concentrated positions. To be considered for lead plaintiff, investors must file by October 20, 2026.

Notice to Institutional Holders

The pleading asserts that Fractyl promoted interim Revita DMR readouts as evidence of durable post-GLP-1 weight maintenance while, as averred, operational deficiencies at one of six REMAIN-1 Midpoint Cohort sites compromised the integrity of the efficacy population. Funds that acquired shares during the Class Period at prices the complaint charges were artificially inflated may have absorbed the resulting decline across index, healthcare sector, and small-cap mandates.

Fiduciary Obligations and Recovery Options

• Fiduciaries under ERISA and comparable state statutes generally review whether identified portfolio losses warrant participation in a pending securities recovery.
• Lead plaintiff appointment is typically sought by the movant with the largest documented financial interest in the relief sought.
• Serving as lead plaintiff provides direct oversight of case strategy, counsel selection, and settlement evaluation.
• Institutions that take no action before the deadline may still participate as absent class members in any eventual recovery.
• Loss assessments are prepared at no cost and without obligation to the fund.

"Institutional investors play a critical role in securities class actions, and courts have long recognized that funds with substantial documented losses are well positioned to oversee counsel. Where a complaint alleges that clinical data supporting two capital raises was compromised by undisclosed site-level issues, fiduciaries may wish to quantify their exposure." -- Joseph E. Levi, Esq.

Contact us to learn more about institutional recovery options or call (212) 363-7500.

INSTITUTIONAL INVESTOR REPRESENTATION — Levi & Korsinsky, LLP provides sophisticated counsel to institutional investors evaluating lead plaintiff opportunities. The firm has recovered hundreds of millions of dollars. Ranked among ISS Top 50 for seven consecutive years.

Frequently Asked Questions About the GUTS Lawsuit

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: 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 the integrity of the REMAIN-1 Midpoint Cohort results during the Class Period. When the six-month data and the outlier site issue were disclosed, the stock price declined sharply.

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 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 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