GUTS DEADLINE: SueWallSt Reminds Fractyl Health, Inc. Investors of Upcoming Securities Class Action Deadline

A chronology of dated disclosure events allegedly shows Fractyl Health promoting Revita DMR weight-maintenance data for a full year before revealing that an "outlier" REMAIN-1 study site skewed the results

NEW YORK, Sept. 01, 2026 (GLOBE NEWSWIRE) -- SueWallSt reminds purchasers of Fractyl Health, Inc. (NASDAQ: GUTS) securities of a pending securities class action brought on behalf of investors who purchased shares between January 13, 2025 and January 29, 2026. See if you could be eligible to recover. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or (888) SueWallSt.

GUTS shares closed at $0.46 on January 30, 2026, down from a Class Period price of $1.83 on January 28, 2026, a cumulative decline of $1.37 per share, or 74.86%. Investors have until October 20, 2026 to seek lead plaintiff status.

Chronology of Material Events

January 13, 2025: Fractyl announced initial one-month results from the first REVEAL-1 patient, stating the findings "align with trends observed in prior Revita clinical studies."

September 26, 2025: The Company reported three-month REMAIN-1 Midpoint Cohort data, describing results as "groundbreaking" and "striking," and stating that Revita-treated patients "lost an additional 2.5% total body weight" versus a 10% regain in sham patients. The same day, Fractyl priced a 60 million share public offering at $1.00 per share.

January 29, 2026: Six-month Midpoint Cohort data showed Revita-treated patients experienced 4.5% weight regain versus 7.5% in the sham arm. A: Shares fell $1.245, or 68.03%, on January 29, 2026, then a further $0.125, or 21.37%, on January 30, 2026.” Shares fell $1.245, or 68.03%, to $0.585.

January 30, 2026: After post-market analyst reports described the outlier site as lacking a dietary center, and a downgrade cut the price target from $8.00 to $2.00, shares fell an additional $0.125, or 21.37%, to $0.46.

Timeline of Alleged Disclosure Failures

• August 5, 2025: A $20 million offering was priced the same day positive two-year registry data was announced, yielding approximately $20.7 million in net proceeds, the filing states.
• August 12, 2025: The Company announced completed enrollment of the 45-participant Midpoint Cohort without disclosing site-level operational issues, as set forth in the complaint.
• September 26, 2025: The September offering generated approximately $56 million in net proceeds, bringing combined Class Period offering proceeds to roughly $76.7 million.
• November 12, 2025: Quarterly filings continued to characterize Midpoint results as "clinically and statistically significant," it is alleged, with no site-level qualification.
• January 5, 2026: Fractyl described 2026 as a "definitional year" weeks before the six-month readout.
• January 29, 2026: Site variability was acknowledged publicly for the first time, according to the complaint.

Alert: Claims Focus on Alleged Misrepresentations About Clinical Site Integrity

The action, pending in the U.S. District Court for the Southern District of New York, alleges that Item 105 of Regulation S-K required disclosure of material factors making an investment speculative or risky, and that ongoing issues at a Midpoint Cohort clinical site were not disclosed.

"The chronology here is what makes this case notable: the complaint alleges that operational issues at a single clinical site were acknowledged only after two capital raises had already closed. Investors are entitled to evaluate that sequence carefully." -- Joseph E. Levi, Esq.

Calculate your potential recovery 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: 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: When did Fractyl Health, Inc. allegedly mislead investors? A: The Class Period runs from January 13, 2025 to January 29, 2026. The complaint alleges that corrective disclosures revealed information that caused a significant stock decline.

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: 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: 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.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@SueWallSt.com
Tel: (888) SueWallSt
Fax: (212) 363-7171

Attorney Advertising. Prior results do not guarantee similar outcomes.