Levi & Korsinsky, LLP alerts investors in Fractyl Health, Inc. (NASDAQ: GUTS) of a pending securities class action on behalf of shareholders who purchased securities between January 13, 2025 and January 29, 2026. Find out if you may be eligible to recover losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.

GUTS closed at a Class Period reference price of $1.83 on January 28, 2026, then fell $1.245 per share (68.03%) to $0.585 on January 29, 2026, and a further $0.125 per share (21.37%) to $0.46 on January 30, 2026 — a cumulative decline of approximately $1.37 per share, or 74.86%. The window to apply for lead plaintiff closes on October 20, 2026.

The Named Individual Defendants

The action names Harith Rajagopalan, Co-Founder, Chief Executive Officer, and Director at all relevant times, and Lisa A. Davidson, who served as Chief Financial Officer at all relevant times until December 31, 2025. Both are alleged to have signed Sarbanes-Oxley Sections 302 and 906 certifications attached to Fractyl’s 2024 Form 10-K and its Q1, Q2, and Q3 2025 quarterly reports, attesting that those filings contained no untrue statement of a material fact.

Alleged Control Person Liability Under Section 20(a)

  • Both officers are alleged to have possessed the power and authority to control the contents of Fractyl’s SEC filings, press releases, and other market communications.
  • The complaint charges that they received copies of the challenged filings and releases before or shortly after issuance and had the ability to prevent or correct them.
  • SOX certifications appended to each periodic report during the Class Period are alleged to have been inaccurate when signed.
  • The pleading asserts that the officers had access to material information about operational issues at a REMAIN-1 Midpoint Cohort clinical site that was not available to the investing public.
  • Filings are alleged to have omitted disclosures required by Item 105 and Item 303 of Regulation S-K concerning speculative or risky factors and known uncertainties.
  • Section 20(a) permits claims against those who allegedly controlled a primary violator of Section 10(b).

“Corporate officers have a duty to ensure their companies’ public statements are accurate and complete. Here, the complaint alleges that certifications were signed while operational conditions at a clinical study site allegedly compromising the integrity of Revita efficacy results went undisclosed.” — Joseph E. Levi, Esq.

Submit your information to learn more or call (212) 363-7500.

Levi & Korsinsky, LLP is a nationally recognized shareholder rights firm. Over the past 20 years, the firm has secured hundreds of millions of dollars for aggrieved shareholders. Ranked in ISS Top 50 for seven consecutive years.

Frequently Asked Questions About the GUTS Lawsuit

Q: Who are the defendants named in the GUTS lawsuit? A: The complaint names Fractyl Health, Inc. and individual defendants including senior executives who signed SEC filings, made public statements, or certified financial disclosures under Sarbanes-Oxley.

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 the integrity of REMAIN-1 Midpoint Cohort weight maintenance results during the Class Period. When six-month Midpoint Cohort data showing 4.5% weight regain for Revita patients versus 7.5% in the sham arm, and an “outlier site” with operational issues, were disclosed, the stock price declined sharply.

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 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 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: Do I need to go to court or give testimony? A: No. The overwhelming majority of class members never appear in court or give depositions. If there is a settlement or recovery, eligible class members generally submit a claim form to seek their portion.

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.

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