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 (NASDAQ: GUTS) is a clinical-stage biotechnology company developing novel therapies targeting the root causes of obesity and type 2 diabetes. This page provides investors and healthcare professionals with timely updates on the company’s progress, including clinical trial results, regulatory milestones, and strategic initiatives.
Key resources include: Press releases detailing advancements in the Revita® duodenal resurfacing procedure, updates on the Rejuva® gene therapy platform, and analyses of pivotal studies like REMAIN-1. Track FDA designations, partnership announcements, and scientific publications demonstrating the company’s unique approach to metabolic disease modification.
All content is rigorously sourced from official company communications and regulatory filings. Bookmark this page to stay informed about Fractyl Health’s progress in developing durable alternatives to chronic medications through its innovative procedural and gene therapy platforms.
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.
Fractyl Health (NASDAQ:GUTS), a metabolic therapeutics company specializing in treatments for obesity and type 2 diabetes, has scheduled two important investor events. The company will release its Q2 2025 financial results and provide business updates on August 12, 2025, at 4:30 p.m. ET.
Additionally, CEO Harith Rajagopalan will present at the Canaccord Genuity 45th Annual Growth Conference on August 13, 2025, at 11:30 a.m. ET. Both events will be accessible via webcast through the company's investor relations website.
Fractyl Health (NASDAQ:GUTS), a metabolic therapeutics company focused on treating obesity and type 2 diabetes, has announced the pricing of a $20 million underwritten public offering. The offering consists of 19,047,619 shares of common stock at $1.05 per share, accompanied by Tranche A (2-year) and Tranche B (5-year) warrants.
Each share comes with two warrants exercisable at $1.05 per share. The Tranche A warrants are callable based on REMAIN-1 study data and specific trading conditions. If all warrants are exercised, the company could receive up to $40 million in additional proceeds. The funds will support Revita and Rejuva pipeline programs and working capital needs.
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