GUTS Investor Alert: Fractyl Health, Inc. Securities Class Action Notice - Contact SueWallSt

Allegations center on operational failures at one of six REMAIN-1 Midpoint Cohort clinical sites, which the complaint contends skewed Revita DMR weight maintenance data that Fractyl Health promoted to investors.

NEW YORK, Sept. 08, 2026 (GLOBE NEWSWIRE) -- SueWallSt reminds purchasers of Fractyl Health, Inc. (NASDAQ: GUTS) securities of a pending securities class action brought on behalf of shareholders who purchased between January 13, 2025 and January 29, 2026. Find out if you might qualify for recovery. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or (888) SueWallSt.

GUTS shares fell $1.245 per share, or 68.03%, to close at $0.585 on January 29, 2026, then fell another $0.125, or 21.37%, to $0.46 on January 30, 2026, a cumulative decline of approximately 74.86% from the $1.83 class period high. Investors have until October 20, 2026 to seek lead plaintiff status.

Clinical Site Execution and the Alleged Data Distortion

On January 29, 2026, Fractyl reported six-month REMAIN-1 Midpoint Cohort data showing 4.5% weight regain in Revita-treated patients versus 7.5% in the sham arm. On the same call, the Company stated that one site "had higher-than-expected regain across both arms." A post-market Canaccord Genuity report attributed the variability at that single site out of six to a "relatively less robust diet and lifestyle counseling program," noting the site "was the first to enroll and hadn't yet set up a dietary center." As set forth in the complaint, this site-level execution gap was never disclosed while the Company promoted the cohort as an "important early randomized readout."

Alleged Trial Execution Impact by the Numbers

• 1 of 6 Midpoint Cohort sites identified as an outlier contributing materially to results
• 45 total participants in the randomized Midpoint Cohort, magnifying single-site influence
• September 2025 data touted an additional 2.5% total body weight loss after GLP-1 discontinuation
• January 2026 data instead showed 4.5% weight regain in the Revita arm
• 40% delta versus sham, below the 50% threshold analysts had referenced
• Morgan Stanley cut its probability of success for Revita from 50% to 35% and its price target from $8.00 to $2.00

"The complaint raises serious questions about whether investors received accurate information about how the REMAIN-1 Midpoint Cohort was being executed at the site level. Trial conduct details that can materially affect reported efficacy are the kind of information shareholders allege they were entitled to receive." -- Joseph E. Levi, Esq.

Submit your information now or call (888) SueWallSt.

WHY SUEWALLST: SueWallSt is powered by Levi & Korsinsky LLP. 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 lead plaintiff deadline? A: The deadline to apply for lead plaintiff appointment is October 20, 2026. This deadline applies only to investors seeking to serve as lead plaintiff. Class members who do not apply may still participate in any recovery without taking action before this date.

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 during the Class Period. When the six-month data and outlier site issues 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 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 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: 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.

CONTACT:

Levi & Korsinsky, LLP

Joseph E. Levi, Esq.

33 Whitehall Street, 27th Floor

New York, NY 10004

jlevi@SueWallSt.com

Tel: (888) SueWallSt

Fax: (212) 363-7171

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