Fractyl Health Stock Price, News & Analysis

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.

Fractyl Health (NASDAQ: GUTS), a metabolic therapeutics company focused on treating obesity and type 2 diabetes, has announced a proposed underwritten public offering of its common stock and pre-funded warrants. The offering includes common warrants to purchase additional shares, with Ladenburg Thalmann & Co. Inc. serving as the sole book-running manager.

The company plans to grant underwriters a 30-day option to purchase up to an additional 15% of shares. Proceeds will support Fractyl's Revita and Rejuva pipeline programs along with working capital needs. The offering is subject to market conditions and will be conducted under a previously filed shelf registration statement that became effective on March 18, 2025.

Fractyl Health (NASDAQ:GUTS) has reported compelling two-year real-world outcomes for its Revita® procedure from the Germany Real-World Registry study. The data shows a median 9.6% weight loss and 1.6% HbA1c reduction in patients with type 2 diabetes, sustained over two years after a single procedure.

The study involved 9 participants with a median baseline weight of 104 kg and HbA1c of 9.6%. After treatment, 7 out of 8 participants achieved ≥5% weight reduction, with median HbA1c improving from 9.6% to 7.0% at two years. Notably, no device or procedure-related serious adverse events were reported.

The company expects key data readouts from its pivotal REMAIN-1 study in Q3 2025, focusing on post-GLP-1 weight maintenance, with primary endpoint data anticipated in H2 2026.

Fractyl Health (NASDAQ: GUTS) reported promising 3-month data from the REVEAL-1 Cohort of its REMAIN-1 pivotal study for Revita, a potential first-in-class weight maintenance therapy. The study showed that 12 out of 13 participants maintained or lost weight after discontinuing GLP-1 therapy and receiving the Revita procedure, with 6 participants achieving additional weight loss. The median weight remained stable with only a 0.46% change (approximately 1 pound), compared to the typical 5-6% weight regain observed after stopping GLP-1 therapy. The treatment demonstrated excellent tolerability with only mild, transient adverse effects. The study included participants who had previously lost at least 15% of their total body weight on GLP-1 therapy, with a median total body weight loss of 20.9%. The company expects Midpoint Cohort data in Q3 2025 and Pivotal Cohort data in H2 2026.