Fractyl Health outlines 2026 Revita pivotal data and PMA submission targets as clinical momentum accelerates [Seeking Alpha]
Fractyl Health, Inc. (GUTS)
Company Research
Source: Seeking Alpha
We delivered the first randomized, double-blind, sham-controlled data showing that a single Revita procedure can sustain weight loss after GLP-1 Quick Insights Revita maintains additional weight loss post-GLP-1 therapy, with consistent results observed over 2 years in the German real-world registry and a significant separation from the sham group in the REMAIN-1 study after tirzepatide discontinuation. Fractyl Health holds $77.7 million in cash and expects its cash runway, boosted by $83 million in recent offerings, to extend into early 2027, supporting ongoing trials and potential commercialization. Key hurdles include securing CPT codes and reimbursement, addressing manufacturing scalability, and achieving favorable pivotal trial outcomes prior to potential PMA submission in the second half of 2026. More Trending News
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News
- Fractyl Health: Unreasonably Low Market Expectations Create A Trading Opportunity Towards 2026 Catalysts [Seeking Alpha]Seeking Alpha
- 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 Announces Compelling 6-Month Randomized REMAIN-1 Midpoint Data Showing Durable Weight Maintenance with Revita® After GLP-1 Discontinuation [Yahoo! Finance]Yahoo! Finance
- Fractyl Health (NASDAQ:GUTS) was downgraded by analysts at Morgan Stanley to a "cautious" rating.MarketBeat
GUTS
Earnings
- 3/3/25 - Miss
GUTS
Sec Filings
- 2/4/26 - Form SCHEDULE
- 1/14/26 - Form 4
- 1/14/26 - Form 3
- GUTS's page on the SEC website