Fractyl Health, Inc. Class Action Lawsuit - GUTS

The filed complaint alleges that Fractyl Health, Inc made materially false and/or misleading statements and/or failed to disclose that: (i) Revita was less effective than defendants had led investors to believe, and/or operational issues at one or more of the REMAIN-1 Midpoint Cohort’s clinical sites compromised the integrity of its efficacy results; (ii) accordingly, Revita’s clinical, regulatory, and commercial prospects were overstated, as was the REMAIN-1 Midpoint Cohort’s ability to assess Revita’s efficacy; and (iii) as a result, defendants’ public statements were materially false and misleading at all relevant times.

In order to be eligible to join the GUTS class action lawsuit, you must have incurred a loss on shares of Fractyl Health, Inc. purchased during the class period listed above.

If you suffered a loss in Fractyl Health, Inc. during the relevant time frame or pursuant to the relevant offering(s), you have until October 20, 2026 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.

Key Facts About Fractyl Health, Inc. (NASDAQ: GUTS)

●       The Allegation: The complaint alleges that Fractyl Health, Inc. overstated Revita's efficacy and prospects for post-GLP-1 weight maintenance while failing to disclose that Revita was less effective than represented and that operational issues at one or more REMAIN-1 Midpoint Cohort clinical sites compromised efficacy results.

●       The Stock Drop: GUTS fell $1.245, or 68.03%, to close at $0.585 per share on January 29, 2026, after Fractyl disclosed six-month REMAIN-1 Midpoint Cohort data and discussed a site issue during an investor call; GUTS then fell $0.125, or 21.37%, to close at $0.46 per share on January 30, 2026, after Canaccord Genuity and Morgan Stanley reports addressed the results and site-specific issues.

●       Class Period & Defendants: The class period runs from January 13, 2025 through January 29, 2026, inclusive. The named defendants are Fractyl Health, Inc., Harith Rajagopalan (Co-Founder, Chief Executive Officer, and Director at all relevant times), and Lisa A. Davidson (Chief Financial Officer at all relevant times until December 31, 2025).

●       Lead Plaintiff Deadline: October 20, 2026. Investors who wish to seek appointment as lead plaintiff must apply by the deadline.

Fractyl Health Class Action Summary
Company	Fractyl Health, Inc. (NASDAQ: GUTS)
Lead Plaintiff Deadline	October 20, 2026
Class Period	January 13, 2025 - January 29, 2026
Stock Drop	January 29, 2026 - GUTS fell $1.245 (68.03%) to $0.585; January 30, 2026 - GUTS fell $0.125 (21.37%) to $0.46

Introduction

A securities class action lawsuit has been filed against Fractyl Health, Inc. in the Southern District of New York. Plaintiff brings the case for investors who acquired Fractyl securities from January 13, 2025 through January 29, 2026.

The complaint alleges defendants made materially false and misleading statements about Revita, Fractyl's treatment candidate for post-GLP-1 weight maintenance. Investors were told that early data showed strong promise, but the lawsuit says key efficacy and site problems were hidden.

When Fractyl released six-month REMAIN-1 Midpoint Cohort data, GUTS dropped sharply. The stock fell 68.03% on January 29, 2026, then fell another 21.37% on January 30, 2026.

Company Profile

Fractyl Health, Inc. is a metabolic therapeutics company developing therapies for type 2 diabetes and obesity. Its lead programs include Revita, an outpatient procedural therapy designed to modify duodenal dysfunction, a condition the complaint describes as a pathologic consequence of a high fat and high sugar diet.

Class Period

January 13, 2025 – January 29, 2026

Investors who purchased or acquired Fractyl Health, Inc. (GUTS) securities during the Class Period may be eligible to seek recovery under the federal securities laws.

Allegations

The Fractyl Health securities lawsuit centers on Revita and the REMAIN-1 study, which is evaluating Revita's ability to maintain weight loss after patients discontinued GLP-1 receptor agonist therapy. According to the complaint, defendants repeatedly promoted interim data from the REVEAL-1 Cohort and the REMAIN-1 Midpoint Cohort, using descriptions such as "groundbreaking," "clinically and statistically significant," and "striking," while emphasizing purported "clear evidence of Revita activity."

The alleged statements began on January 13, 2025, when Fractyl announced promising initial clinical results from the first patient in the REVEAL-1 open-label cohort. The company said the patient maintained weight loss one month after GLP-1 discontinuation and the Revita procedure, while comparing that result with prior studies showing average weight regain after GLP-1 withdrawal. In later March, April, May, June, and August 2025 releases and SEC filings, Fractyl continued to state that early clinical signals supported Revita's potential and that the REMAIN-1 Midpoint Cohort would provide an important randomized readout.

The complaint further alleges that defendants amplified those claims in September 2025, when Fractyl reported three-month REMAIN-1 Midpoint Cohort data. The company stated that the pilot study met a key three-month efficacy endpoint with strong statistical significance, and reported that Revita-treated patients lost an additional 2.5% total body weight after stopping GLP-1 drugs, compared with 10% regain in sham-treated patients. The company also stated that the Midpoint Cohort was designed to be identical to the ongoing Pivotal Cohort, which allegedly reinforced investor expectations that the results validated Revita's broader clinical program.

The complaint alleges those statements were materially false and misleading because defendants failed to disclose that Revita was less effective than represented and that operational issues at one or more REMAIN-1 Midpoint Cohort clinical sites compromised the integrity of efficacy results. The complaint also claims that Fractyl overstated Revita's clinical, regulatory, and commercial prospects, and overstated the REMAIN-1 Midpoint Cohort's ability to assess Revita's efficacy. According to the complaint, those omissions also implicated Item 105 and Item 303 of Regulation S-K because site issues and degrading efficacy results were material risks or known trends and uncertainties.

The Truth Emerges

The alleged truth began to emerge during pre-market hours on January 29, 2026, when Fractyl issued a press release announcing six-month REMAIN-1 Midpoint Cohort data. The company disclosed that, across the prespecified efficacy population, Revita-treated patients experienced 4.5% weight regain versus 7.5% in the sham arm at six months. The press release also stated that the Midpoint Cohort was not designed to be sufficiently powered for efficacy analysis.

During a same-day investor and analyst conference call, Harith Rajagopalan discussed variability at one REMAIN-1 Midpoint Cohort study site. He stated that central statistical monitoring had identified one site with a high degree of variability in weight regain, and that one site was contributing materially to the results. In response to a Morgan Stanley analyst's question, he said the higher weight gain was related to the site issue and that the site had higher-than-expected regain across both arms.

After the market closed on January 29, 2026, analyst reports added detail and caution. Canaccord Genuity reported that management attributed variability at one outlier site, out of six, to a less robust diet and lifestyle counseling program, noting that the site was first to enroll and had not yet set up a dietary center. Morgan Stanley downgraded Fractyl to "Equal-weight" from "Overweight," cut its price target to $2.00 from $8.00, characterized the six-month Revita results as disappointing, and lowered its probability of success for Revita to 35% from 50%.

Market Reaction

Following the January 29, 2026 disclosures, Fractyl's stock price fell $1.245 per share, or 68.03%, to close at $0.585 per share. The complaint links that decline to the six-month REMAIN-1 Midpoint Cohort data and the company's discussion of a clinical site issue that affected the results.

The next trading day, after the Canaccord Genuity and Morgan Stanley reports, GUTS fell another $0.125 per share, or 21.37%, to close at $0.46 per share on January 30, 2026. The complaint alleges these declines damaged investors who acquired Fractyl securities at artificially inflated prices during the class period.

Next Steps

●       Lead Plaintiff Deadline: October 20, 2026

●       After the lead plaintiff deadline, the Court will consider any lead plaintiff motions.

●       Defendants may file a motion to dismiss.

●       If the case proceeds, the Court may later consider class certification.

Disclaimer: This shareholder alert is for informational purposes only and does not constitute legal advice. Consult a qualified attorney for personalized guidance. Prior results do not guarantee similar outcomes.