Welcome to our dedicated page for Fractyl Health news (Ticker: GUTS), a resource for investors and traders seeking the latest updates and insights on Fractyl Health stock.
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 Q1 2026 net income of $9.2 million, versus a $23.7 million loss a year ago, driven by a non-cash warrant liability revaluation. R&D fell to $15.6 million, adjusted EBITDA was -$18.0 million, and cash totaled $63.2 million, funding operations into early 2027.
The company completed randomization of the REMAIN-1 Pivotal Cohort for Revita, reaffirmed key 2026 data and regulatory milestones, received FDA feedback supporting a potential Class II device classification, and obtained CTA authorization in the Netherlands for first-in-human testing of gene therapy candidate RJVA-001 in T2D.
Fractyl Health (Nasdaq:GUTS) received authorization in the Netherlands to begin a Phase 1/2 first-in-human trial of RJVA-001, the first clinical candidate from its Rejuva Smart GLP-1 gene therapy platform.
Fractyl believes RJVA-001 is the first AAV-based gene therapy to enter clinical development for type 2 diabetes. The company expects first dosing and preliminary data in 2H 2026, subject to site activation, and says Rejuva development is funded within its existing cash runway into early 2027 with no change to capital plans, while Revita remains in pivotal development for post-GLP-1 weight maintenance.
Fractyl Health (Nasdaq: GUTS) will report first quarter 2026 financial results and provide business updates on May 12, 2026 at 4:30 p.m. ET. A live webcast and archived replay will be available in the company’s Events section at http://ir.fractyl.com.
CEO Harith Rajagopalan, M.D., Ph.D. will present at the BofA Securities 2026 Health Care Conference on May 14, 2026 at 9:20 a.m. PT (12:20 p.m. ET); that presentation will also be webcast and archived.
Fractyl Health (Nasdaq: GUTS) reported Q4 and full-year 2025 results, clinical progress, and regulatory milestones. Key clinical highlights include completion of REMAIN-1 pivotal randomization, dose-dependent 6-month post-GLP-1 weight‑maintenance effects in midpoint analyses, and anticipated topline pivotal data in early Q4 2026. The company reiterated cash runway into early 2027 and noted favorable FDA pre-submission feedback toward a potential De Novo submission in late Q4 2026.
Fractyl Health (Nasdaq: GUTS) will report fourth quarter and full year 2025 financial results and provide business updates on March 24, 2026 at 4:30 p.m. ET. A live webcast and presentation will be available in the company’s Events section at http://ir.fractyl.com and archived for replay after the live event.
Fractyl Health (Nasdaq: GUTS) completed randomization in the REMAIN-1 Pivotal Cohort evaluating Revita for weight maintenance after GLP-1 discontinuation. Topline 6-month pivotal data are expected in early Q4 2026, with a potential FDA marketing application in late Q4 2026. The company reiterates cash runway into early 2027.
The randomized, double-blind, sham-controlled study enrolled adults with BMI 30–45 kg/m2 who lost ≥15% body weight on tirzepatide and randomizes 2:1 Revita versus sham; co-primary endpoints target 6-month percent weight regain and 12-month ≥5% responder rate.
Fractyl Health (Nasdaq: GUTS) reported positive 6-month randomized REMAIN-1 Midpoint data showing durable weight maintenance with Revita after GLP-1 discontinuation. Key findings: Revita reduced mean weight regain to 4.5% vs 7.5% for sham (p=0.07, one-sided) and ~70% less regain in above-median GLP-1 responders (4.2% vs 13.3%; p=0.004).
Supportive cardiometabolic signals included higher HDL (15.5 vs 3.9 mg/dL; p=0.01) and improved triglyceride-to-HDL ratio. No device- or procedure-related serious adverse events were reported. Company expects pivotal topline 6-month data and potential FDA filing in H2 2026; FDA De Novo feedback expected Q2 2026.
Fractyl Health (Nasdaq: GUTS) announced the appointment of Lara Smith Weber as Chief Financial Officer, effective January 12, 2026, to lead finance, accounting, and investor relations as the company prepares for commercial-stage operations.
The release notes Ms. Smith Weber brings 20+ years of financial leadership in medtech and biotech, prior CFO roles at Inari and ONWARD Medical, and experience preparing organizations for commercialization. Longtime CFO Lisa Davidson resigned effective December 31, 2025 and will provide consulting support during the transition.
Fractyl Health (Nasdaq: GUTS) outlined a 2026 roadmap centered on pivotal clinical and regulatory milestones for its Revita and Rejuva programs and reported $85.6 million in cash and equivalents as of Jan 2, 2026.
Key near-term events include randomized 6-month REMAIN-1 Midpoint data in late January 2026, completion of REMAIN-1 pivotal cohort randomization in early 2026, REVEAL-1 1-year data in Q2 2026, and topline 6-month pivotal data with a potential Revita PMA filing in H2 2026. Rejuva aims for regulatory feedback in Q2 2026 and possible first-in-human dosing in H2 2026, subject to authorization.
Fractyl Health (Nasdaq: GUTS) announced it will call all outstanding Tranche A common stock purchase warrants, giving holders until 6:30 p.m. ET on December 30, 2025 to exercise at $1.05 per share or accept cancellation for $0.00001 per underlying share.
The company has ~17,063,073 Tranche A Warrants outstanding; full exercise would generate up to $17.9 million in gross proceeds before fees. The call was enabled after Fractyl released positive three-month randomized midpoint data from the REMAIN-1 study and met trading conditions, including an average closing price above $1.37 for 15 consecutive trading days; the last reported Nasdaq sale price on December 15, 2025 was $2.24.