Fractyl Health, Inc. reports clinical and corporate developments as a clinical-stage metabolic therapeutics company focused on obesity and type 2 diabetes. Its lead product candidate, Revita®, is a minimally invasive endoscopic therapy designed to remodel the duodenal lining for post-GLP-1 weight maintenance; it is investigational in the United States, has FDA Breakthrough Device designation, and is CE marked in the European Union and United Kingdom.
Company news also covers the Rejuva® AAV-based gene therapy platform, including RJVA-001 for type 2 diabetes and RJVA-002 for obesity, as well as clinical data from REMAIN-1, regulatory authorizations, financial results, capital-plan updates and public-company governance changes.
Fractyl Health (Nasdaq: GUTS) reported positive 6-month open-label REVEAL-1 results showing sustained post-GLP-1 weight maintenance after a single Revita procedure.
Key data: participants previously lost 24% total body weight (>50 lbs) on GLP-1s; at 6 months after GLP-1 discontinuation plus one Revita treatment mean total body weight change was +1.5% ±1.3% (SEM; n=17) and mean HbA1c change was +0.04% ±0.08% (SEM; n=17). Safety: no procedure-related serious adverse events; 36% experienced transient mild TEAEs (8/22).
Upcoming milestones include REMAIN-1 randomized 6-month midpoint data in Jan 2026 and potential PMA filing in H2 2026.
Fractyl Health (Nasdaq: GUTS) announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference in Coral Gables, FL.
Event format: fireside chat and one-on-one meetings. Date and time: December 3, 2025 at 1:45 PM ET. A webcast replay will be available on the company’s investor events page at https://ir.fractyl.com/.
Fractyl Health (Nasdaq: GUTS) reported Q3 2025 results and clinical progress for Revita and Rejuva. Key clinical highlights include positive randomized 3-month REMAIN-1 Midpoint data showing Revita-treated patients lost an additional 2.5% total body weight versus sham patients who regained 10% after tirzepatide discontinuation (p=0.014), and 6-month REVEAL-1 data expected in Q4 2025. The REMAIN-1 Pivotal Cohort is fully enrolled (n=315) with >60% randomized as of Oct 31, 2025; 6-month pivotal topline data and potential PMA filing are targeted in H2 2026. Preclinical RJVA-002 produced ~30% weight loss in five weeks. The company completed $83M in underwritten offerings, and had $77.7M cash on Sept 30, 2025, with runway into early 2027.
Fractyl Health (Nasdaq: GUTS) will report third quarter 2025 financial results and provide business updates on Wednesday, November 12, 2025 at 4:30 p.m. ET. A live webcast of the conference call and presentation will be available in the Events section of Fractyl Health’s investor website at http://ir.fractyl.com. The webcast will be archived and available for replay following the live event.
Fractyl Health (Nasdaq: GUTS) reported preclinical data showing a single administration of RJVA-002 produced substantial, dose-dependent weight loss in a diet-induced obesity mouse model with a humanized GIP receptor.
Key measured effects: ~30% weight loss by five weeks (high dose) with trajectory not yet plateaued; mid- and high-dose cohorts lost mean 18% (p<0.01) and 29% (p<0.0001) body weight by day 35; no adverse effects observed. RJVA-002 encodes GIP and GLP-1 under an engineered insulin promoter. RJVA-001 is expected to enter first-in-human trials in 2026.
Fractyl Health (NASDAQ:GUTS), a metabolic therapeutics company specializing in treatments for obesity and type 2 diabetes, has announced the pricing of an underwritten public offering of 60 million shares of common stock at $1.00 per share.
The company expects to raise $60 million in gross proceeds before deducting underwriting discounts, commissions, and offering expenses. The offering is anticipated to close around September 29, 2025. BofA Securities and Evercore ISI are serving as joint book-running managers, with Ladenburg Thalmann acting as lead manager.
Fractyl Health (NASDAQ: GUTS) announced breakthrough results from their REMAIN-1 Midpoint Cohort study evaluating Revita® for weight maintenance after GLP-1 discontinuation. The study demonstrated that Revita-treated patients lost an additional 2.5% total body weight after stopping tirzepatide, while sham patients regained 10% (p=0.014).
The randomized, double-blind study (N=45) involved adults with obesity who achieved ≥15% weight loss with tirzepatide. The trial showed excellent safety with no Revita-related serious adverse events. These results support Revita's potential as the first therapy for post-GLP-1 weight maintenance, with pivotal study data expected in H2 2026.
Fractyl Health (NASDAQ: GUTS), a metabolic therapeutics company, has strengthened its Board of Directors with two strategic appointments. Dr. Christopher Thompson, a Harvard Medical School Professor and pioneer in bariatric endoscopy, and Ian Sheffield, an experienced healthcare investor, have joined the board as the company approaches critical milestones.
The appointments come at a pivotal time as Fractyl advances two key products: Revita®, which expects randomized data from its Midpoint Cohort this month, and Rejuva®, a gene therapy platform moving toward first-in-human clinical trials. These appointments aim to enhance the company's clinical execution and strategic growth as it transitions into a late-stage, pre-commercial organization focused on treating obesity and type 2 diabetes.
Fractyl Health (NASDAQ: GUTS) reported Q2 2025 financial results and business updates for its metabolic therapeutics platforms. The company completed a $23 million public offering to extend its cash runway. Key highlights include positive 3-month data from the REVEAL-1 Cohort, where 12 of 13 participants maintained or reduced weight after GLP-1 discontinuation and Revita® procedure.
The company expects several major milestones, including REMAIN-1 Midpoint Cohort data in September 2025 and REMAIN-1 Pivotal Cohort data in H2 2026. Q2 financials show R&D expenses of $21.2M and a net loss of $27.9M. The company's cash position of $22.3M, plus recent offering proceeds, is expected to fund operations into 2026.
Fractyl Health (NASDAQ:GUTS) has successfully closed its previously announced underwritten public offering, raising $23 million in gross proceeds. The offering included 21,904,761 shares of common stock with accompanying Tranche A (2-year) and Tranche B (5-year) warrants, sold at $1.05 per combined unit.
Notable institutional investors participating included Nantahala Capital, ADAR1 Capital Management, Second Line Capital, 683 Capital, and SilverArc Capital. The warrants, if fully exercised, could provide up to an additional $46 million in gross proceeds. The company plans to use the funds to support clinical development of its Revita and Rejuva platforms and for working capital purposes.