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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GUTS
News
- Fractyl Health (NASDAQ:GUTS) had its "buy" rating reaffirmed by analysts at HC Wainwright. They now have a $8.00 price target on the stock.MarketBeat
- Fractyl Health Reports Positive 6-Month REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® ProcedureGlobeNewswire
- Fractyl Health to Participate in the 8th Annual Evercore Healthcare ConferenceGlobeNewswire
- Fractyl Health (NASDAQ:GUTS) had its price target raised by analysts at Canaccord Genuity Group Inc. from $6.00 to $8.00. They now have a "buy" rating on the stock.MarketBeat
- Fractyl Health Reports Third Quarter 2025 Results; Revita® Clinical Momentum Builds Toward 2026 Pivotal Readout and PMA Filing, Cash Runway Extended into Early 2027 [Yahoo! Finance]Yahoo! Finance
GUTS
Earnings
- 3/3/25 - Miss
GUTS
Sec Filings
- 12/2/25 - Form 8-K
- 11/14/25 - Form SCHEDULE
- 11/14/25 - Form SCHEDULE
- GUTS's page on the SEC website