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 (GUTS) is concentrating resources on Revita for post-GLP-1 weight maintenance and plans to reduce its workforce by approximately 45%. Internal development of the Rejuva gene therapy program will stop while strategic alternatives are sought. The changes follow REMAIN-1 pivotal results meeting the prespecified six-month co-primary endpoint for weight regain versus sham (p=0.0023).
Fractyl plans an FDA De Novo marketing application in late Q4 2026 and expects 12-month pivotal data, including the second co-primary endpoint, in Q1 2027. It identifies late 2027 as potential authorization timing and early 2028 for a potential U.S. launch. The company expects existing cash to fund operations into Q2 2027 and quarterly operating cash burn to fall approximately 50% to approximately $8 million by that quarter's end. Workforce reductions are expected to be substantially completed by November 2026.
Fractyl Health (Nasdaq: GUTS) reported that Revita met its six-month co-primary endpoint in the ongoing REMAIN-1 study of post-GLP-1 weight maintenance. The randomized, double-blind, sham-controlled study enrolled 308 adults with obesity. Revita participants retained approximately 80% of GLP-1-induced weight loss versus 67% with sham; adjusted mean weight regain was 5.1% versus 8.2% (p=0.0023).
Post hoc analyses found less regain with longer duodenal ablation, a procedure treating the small intestine's lining. No device- or procedure-related serious adverse events occurred through September 24, 2026. Fractyl plans a late Q4 2026 FDA De Novo marketing application and expects one-year data, including the second co-primary endpoint, in Q1 2027. Potential authorization is targeted for late 2027 and a potential U.S. launch for early 2028. The FDA will determine the final regulatory pathway after reviewing the complete safety dataset.
Fractyl Health (GUTS) will participate in two investor conferences in September 2026 featuring CEO Harith Rajagopalan. The company will present an on-demand session and hold one-on-one meetings at the H.C. Wainwright 28th Annual Global Investment Conference, with the presentation available starting September 11, 2026 at 7:00 AM ET and meetings on September 15, 2026. Fractyl will also host a fireside chat and one-on-one meetings at the Morgan Stanley 24th Annual Global Healthcare Conference on September 14, 2026 at 5:35 PM ET. Live and on-demand webcasts for both events will be available via the Events section of the company’s investor relations website and will remain accessible for 90 days.
Fractyl Health (Nasdaq: GUTS) will host a virtual Commercial Strategy Day on Tuesday, September 1, 2026 at 11:00 AM ET to discuss the potential commercial opportunity and go-to-market strategy for Revita, a procedural therapy for post-GLP-1 weight maintenance.
The event follows positive one-year randomized data from the REMAIN-1 Midpoint Cohort, where an optimized Revita-treated population maintained about 84% of GLP-1-induced weight loss versus 46% in sham (least squares mean weight regain 4.1% vs 13.5%; n=10 vs 8). Management will also outline the anticipated early Q4 2026 six-month topline readout of the REMAIN-1 Pivotal Cohort, plans for a potential FDA De Novo marketing application in late Q4 2026, and steps toward commercial readiness. A live webcast and 90-day replay will be available in the company’s investor relations “Events” section.
Fractyl Health (Nasdaq:GUTS) reported Q2 2026 results and key clinical milestones for its Revita and Rejuva programs. Revita one-year data from the REMAIN-1 Midpoint Cohort showed patients with complete duodenal ablation maintained about 84% of prior GLP‑1‑induced weight loss versus 46% with sham, with no device- or procedure-related serious adverse events through one year. Open-label REVEAL-1 Cohort patients maintained about 78% of GLP‑1‑induced weight loss after a single Revita procedure.
For Q2 2026, research and development expenses fell to $13.8 million from $21.2 million, net loss narrowed to $25.5 million from $27.9 million, and Adjusted EBITDA loss improved to $16.3 million from $24.0 million. Fractyl reported $47.1 million in cash and cash equivalents, guiding runway into early 2027, and reiterated timelines for REMAIN‑1 Pivotal data in early Q4 2026, a potential FDA De Novo submission in late Q4 2026, and first-in-human dosing of Rejuva candidate RJVA‑001 in H2 2026.
Fractyl Health (Nasdaq: GUTS), a clinical-stage metabolic therapeutics company focused on obesity and type 2 diabetes, announced it will report its second quarter 2026 financial results and provide business updates on Monday, August 10, 2026, at 4:30 p.m. ET.
According to Fractyl Health, investors and the public can access a live webcast of the conference call and presentation in the “Events” section of its investor relations website at http://ir.fractyl.com. The webcast will be archived for replay after the live event.
Fractyl Health (Nasdaq: GUTS) announced that CEO and Co-Founder Harith Rajagopalan, M.D., Ph.D., will participate in three upcoming investor events: the BTIG Virtual Biotechnology Conference (one-on-one meetings, July 28–29, 2026), the Needham & Company MedTech & Diagnostics 1x1 Conference (one-on-one meetings, August 10–11, 2026), and the Canaccord Genuity 46th Annual Growth Conference (fireside chat and one-on-one meetings, August 12, 2026, 8:30 AM ET). A live webcast of the event will be available in the “Events” section of Fractyl Health’s investor relations website and will remain archived for 90 days.
Fractyl Health (Nasdaq:GUTS) reported one-year randomized data from the REMAIN-1 Midpoint Cohort evaluating the Revita DMR System for post-GLP-1 weight maintenance after tirzepatide discontinuation. In the mITT population (N=45), least-squares mean weight regain was 7.8% with Revita versus 13.0% with sham at one year.
Among participants with complete duodenal ablation (>14 cm), Revita patients maintained about 81% of GLP-1-induced weight loss versus 48% with sham, corresponding to 4.8% versus 13.0% weight regain. In an optimized subgroup (complete ablation and ≥17.5% run-in weight loss), approximately 84% of weight loss was maintained with Revita versus 46% with sham (4.1% versus 13.5% regain).
The weight-maintenance responder rate reference for the Pivotal Cohort was 73% in the Midpoint mITT population and 91% with complete ablation. No device- or procedure-related serious adverse events were reported, TEAE rates were similar between arms, and no new device-related TEAEs occurred from six to 12 months. Fractyl highlighted upcoming milestones: topline six-month Pivotal Cohort data in early Q4 2026 and a potential FDA De Novo submission in late Q4 2026.
Fractyl Health (Nasdaq:GUTS) reported positive one-year open-label REVEAL-1 results for its Revita® procedure in people with obesity discontinuing GLP-1 drugs.
Participants maintained ~78% of prior GLP-1-induced weight loss; mean total body weight change was 5.3% (n=15). HbA1c rose only 0.08%, with no procedure-related serious adverse events. One-year randomized REMAIN-1 Midpoint data are expected in Q3 2026 and six-month Pivotal Cohort data in early Q4 2026.
Fractyl Health (Nasdaq:GUTS) appointed Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy. He will build reimbursement and health economics infrastructure for Revita ahead of anticipated REMAIN-1 pivotal cohort topline data in early Q4 2026 and a potential De Novo marketing application in late Q4 2026.
Zumdahl previously led global health economics, market access, and government affairs at Inari Medical through its approximately $4.9 billion acquisition by Stryker and held GLP-1-focused roles at Novo Nordisk.