Fractyl Health Stock Price, News & Analysis

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.

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 Q1 2025 financial results and provide business updates on May 13, 2025, at 4:30 p.m. ET via a live webcast.

Additionally, CEO and Co-Founder Harith Rajagopalan, M.D., Ph.D., will present at the BofA Securities 2025 Health Care Conference on May 14, 2025, at 5:00 p.m. PT. Both events will be accessible through the company's investor relations website, with recordings available for replay after the live presentations.

Fractyl Health (Nasdaq: GUTS) announced an upcoming presentation of preclinical data for their innovative Rejuva Smart GLP-1 pancreatic gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting in New Orleans.

Key highlights:

• The presentation focuses on a single-administration therapy targeting obesity and type 2 diabetes root causes
• Research title: "Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model"
• Scheduled for May 17, 2025, at 9:15 AM CT in NOLA Theater A
• Part of the AAV Preclinical and Proof-of-Concept Studies session

The presentation materials will be accessible through the Presentations & Publications section of Fractyl's website after the event concludes on May 17, 2025.

Fractyl Health (NASDAQ: GUTS) has reported promising early data from its REVEAL-1 study, suggesting that its Revita® procedure may help prevent weight regain after patients discontinue GLP-1 medications. The study shows that at 1-month post-procedure, 7 patients experienced an average weight regain of just 1.2%, compared to the typical 3% regain observed after GLP-1 discontinuation.

The REVEAL-1 cohort, part of the ongoing REMAIN-1 pivotal study, has treated 15 patients to date, with no safety or tolerability concerns reported. This safety profile aligns with previous data from over 100 treated patients. The company's REMAIN-1 pivotal study is now more than 50% enrolled, with a midpoint data analysis expected in Q3 2025.

Revita, which holds FDA Breakthrough Device designation, is being studied under an open Investigational Device Exemption. The company aims to position it as the first approved intervention specifically for post-GLP-1 weight maintenance, addressing a growing unmet need in obesity treatment.

Fractyl Health (NASDAQ: GUTS) reported its Q4 and full year 2024 financial results, highlighting strong progress in its REMAIN-1 pivotal study for weight maintenance post-GLP-1 therapy. The study has enrolled 189 patients across 13 clinical sites in six months, with midpoint data analysis expected in Q2 2025 and full enrollment by summer 2025.

Key financial metrics for Q4 2024 include:

• R&D expenses increased to $20.3M (vs $10.1M in Q4 2023)
• SG&A expenses rose to $4.9M (vs $2.8M in Q4 2023)
• Net loss widened to $25.0M (vs $19.2M in Q4 2023)
• Cash position of $67.5M as of December 31, 2024

The company plans to submit its first Clinical Trial Application module for RJVA-001 in type 2 diabetes in H1 2025, with preliminary data expected in 2026. Fractyl has strategically focused on weight maintenance and extended its cash runway into 2026.

Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company specializing in treatments for obesity and type 2 diabetes (T2D), has announced it will release its fourth quarter and full year 2024 financial results on March 3, 2025, at 4:30 p.m. ET. The company will also provide business updates during the event.

A live webcast of the conference call will be available in the 'Events' section of Fractyl's investor relations website, with a replay option available after the event.