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), 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.
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