Fractyl Health (GUTS) Stock News, May-Aug 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.

Fractyl Health (NASDAQ: GUTS) presented promising preclinical data for its Rejuva Smart GLP-1 pancreatic gene therapy platform at ADA's 85th Scientific Sessions. The study demonstrated that a single dose of Rejuva prevented obesity and type 2 diabetes in mice exposed to high-fat diets, showing a 20% reduction in body weight and 38% decrease in blood glucose by day 21. The therapy's unique mechanism enables nutrient-responsive secretion, activating only under metabolic stress while remaining inactive in healthy conditions. The treatment was well-tolerated with no toxicity signs. Fractyl expects to begin human trials with its first clinical candidate RJVA-001 and report preliminary data in 2026, positioning it as a potential first-in-class gene therapy for metabolic control.

Fractyl Health (NASDAQ: GUTS) has strengthened its intellectual property portfolio with two new U.S. patents focused on duodenal resurfacing technology for treating metabolic diseases. The patents (No. 12,329,439 and No. 12,303,185) cover ablation of duodenal mucosa using thermal and non-thermal electrical energy. The company's IP portfolio now includes 31 granted U.S. patents and approximately 40 pending U.S. applications. Fractyl's Revita® treatment represents a first-in-class therapy for obesity and type 2 diabetes, with clinical data from hundreds of treated patients. The company anticipates three key data readouts: REVEAL-1 Cohort open-label data in June 2025, REMAIN-1 Midpoint Cohort data in Q3 2025, and REMAIN-1 Pivotal Cohort 6-month primary endpoint data in H2 2026.

Fractyl Health (NASDAQ: GUTS), a metabolic therapeutics company, will present new preclinical data from its Rejuva Smart GLP-1 pancreatic gene therapy platform at the American Diabetes Association's 85th Scientific Sessions. The presentation, scheduled for June 22, 2025, will showcase results from a study titled 'Single-Dose GLP-1–Based Pancreatic Gene Therapy Prevents Obesity and Diabetes in High-Fat–Fed Mice.' The poster session will take place at the ADA conference in Chicago from June 20-23, 2025, with the specific presentation scheduled for 12:30-1:30 PM in Hall F1. The data will be made available on Fractyl's website after the conference presentation.

Fractyl Health (NASDAQ: GUTS) and Bariendo have signed a Letter of Intent to explore collaboration for implementing Fractyl's investigational Revita procedure across Bariendo's nationwide bariatric and metabolic endoscopy centers. Revita, pending FDA approval, is being developed as a potential solution for weight maintenance after GLP-1 drug discontinuation. The outpatient endoscopic procedure targets the duodenal lining to address root causes of obesity. Three key data readouts are expected: REVEAL-1 Cohort data in June 2025, REMAIN-1 Midpoint Cohort data in Q3 2025, and REMAIN-1 Pivotal Cohort primary endpoint data in H2 2026. The collaboration aims to develop operational readiness for Revita's integration into clinical offerings, focusing on workflow design, provider education, and health economic analysis.

Fractyl Health (NASDAQ: GUTS) has submitted the first module of its Clinical Trial Application (CTA) in Europe for RJVA-001, a novel gene therapy candidate targeting type 2 diabetes and obesity. RJVA-001 is designed to express GLP-1 locally in pancreatic beta cells using nutrient-responsive control, delivered through a one-time, minimally invasive endoscopic procedure. The therapy aims to enable physiologic hormone secretion without the high circulating levels associated with side effects in traditional GLP-1 drugs. Recent preclinical data presented at ASGCT 2025 demonstrated safety and dose-dependent potency. Pending regulatory approval, Fractyl expects to begin first-in-human dosing and report preliminary data in 2026.

Fractyl Health (NASDAQ: GUTS) presented promising preclinical data for RJVA-001, its Rejuva® Smart GLP-1™ pancreatic gene therapy platform, at ASGCT 2025. The data showed that a single dose of RJVA-001 achieved durable metabolic improvements in diabetic mice, including a >200 mg/dL reduction in fasting blood sugar and prevention of weight gain. Notably, RJVA-001 demonstrated 5-fold lower systemic GLP-1 exposure compared to current GLP-1 drugs, suggesting reduced side effects. The therapy showed targeted pancreatic expression through endoscopic ultrasound-guided delivery in large animal studies, with no observed toxicity. The platform demonstrated nutrient-responsive GLP-1 secretion, mimicking natural hormone regulation. Fractyl Health plans to submit its first CTA module for RJVA-001 by June 2025, with preliminary human data expected in 2026.

Fractyl Health (NASDAQ: GUTS) reported Q1 2025 financial results and provided updates on its metabolic therapeutics programs. The company's key focus is on maintaining weight loss after GLP-1 therapy discontinuation. Key highlights include: - REVEAL-1 Cohort showed promising early results with only 1.2% weight regain vs typical 3% after GLP-1 discontinuation - REMAIN-1 Midpoint Cohort (45 participants) completed enrollment, with data expected in Q3 2025 - REMAIN-1 Pivotal Cohort (315 participants) completed enrollment ahead of schedule - Rejuva gene therapy platform advancing with first CTA module submission planned for June 2025 Financial results show R&D expenses of $19.4M (up from $14.4M in Q1 2024), net loss of $23.7M (vs $3.3M in Q1 2024), and cash position of $42.1M, expected to fund operations into Q4 2025.