Fractyl Health Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita® After GLP-1 Discontinuation [Yahoo! Finance]
Fractyl Health, Inc. (GUTS)
Company Research
Source: Yahoo! Finance
Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months Results support pivotal study design and further substantiate Revita's potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6-month pivotal data and potential FDA filing expected in H2 2026 Based on ongoing interactions and favorable safety data to date, the Company has requested FDA feedback on reclassifying Revita under the De Novo pathway, which is expected in Q2 2026 Company to host investor call and webcast today at 8:00 a.m. ET BURLINGTON, Mass., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a metabolic therapeutics company developing disease-modifying solutions for obesity and type 2 diabetes, today announced positive six-month randomized results from the ongoing REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita ® for
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GUTS
News
- Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTSBusiness Wire
- Fractyl Health (GUTS) Tests Whether Revita Can Redefine Post-GLP-1 Weight Maintenance Economics [Yahoo! Finance]Yahoo! Finance
- Fractyl Health (NASDAQ:GUTS) was downgraded by analysts at Morgan Stanley to a "cautious" rating.MarketBeat
- Fractyl Health, Inc. Investigated on Behalf of Investors - Contact the DJS Law Group to Discuss Your Rights – GUTSBusiness Wire
- Fractyl Health Appoints Lara Smith Weber as Chief Financial Officer to Support Commercial-Stage PreparednessGlobeNewswire
GUTS
Earnings
- 3/3/25 - Miss
GUTS
Sec Filings
- 1/14/26 - Form 4
- 1/14/26 - Form 3
- 1/13/26 - Form S-8
- GUTS's page on the SEC website