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. (Nasdaq: GUTS) is a metabolic therapeutics company focused on new approaches to obesity and type 2 diabetes (T2D), and its news flow centers on clinical data, regulatory progress, and financing activities that support these programs. The company’s updates frequently highlight developments in its Revita® endoscopic therapy and Rejuva® gene therapy platform, along with corporate and capital markets milestones.
News about Revita often covers results from the REMAIN weight maintenance program and the REVEAL‑1 Cohort, which evaluate Revita’s potential to maintain weight loss after GLP‑1 drug discontinuation. Fractyl Health has reported randomized data from the REMAIN‑1 Midpoint Cohort and open‑label data from REVEAL‑1, as well as progress in the REMAIN‑1 Pivotal Cohort and a Germany real‑world registry in inadequately controlled T2D. These releases provide detail on study designs, endpoints, safety observations, and anticipated timelines for additional data and a potential PMA submission.
Coverage of the Rejuva platform includes preclinical results from RJVA‑001 and RJVA‑002, the submission of a Clinical Trial Application module for RJVA‑001 in T2D, and presentations at scientific meetings. The company’s news describes how Rejuva is being developed as an AAV‑based, locally delivered gene therapy approach intended to support long‑term metabolic control.
Investors following GUTS news will also see announcements related to underwritten offerings of common stock, warrant structures and calls, cash runway guidance, board appointments, executive changes, and participation in healthcare conferences. Together, these items provide context on how Fractyl Health is advancing its investigational therapies, managing its capital position, and preparing for potential late‑stage and commercial‑stage activities in metabolic disease.
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.
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.