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) announced the acceleration of its REMAIN-1 clinical study, focusing on Revita's effectiveness in maintaining weight loss post-GLP-1 therapy discontinuation. Open label data from the REVEAL-1 cohort is expected in Q4 2024, with mid-point analysis by Q2 2025. The FDA approved an amendment expanding the Revita study (REVITALIZE-1) to include patients inadequately controlled on any glucose-lowering agent, significantly increasing the eligible U.S. treatment population. Additionally, Fractyl presented preclinical data at the ADA's 84th Scientific Sessions, showing greater and more durable weight loss with Rejuva® therapy compared to semaglutide. The company aims to address the high weight regain rates post-GLP-1 therapy and enhance glucose regulation for T2D patients.
Fractyl Health presented new preclinical data on its Rejuva® GLP-1 pancreatic gene therapy at the ADA's 84th Scientific Sessions. The studies showed that a single administration of Rejuva reduced fat mass by 21%, improved glycemia, and retained lean mass in a diet-induced obesity (DIO) mouse model. Post-semglutide withdrawal, Rejuva maintained a 17% reduction in fat and 22% weight loss. These findings suggest Rejuva can mimic natural GLP-1 release and sustain weight and glycemic improvements, addressing a critical need for a long-lasting obesity and T2D treatment.
Fractyl Health (Nasdaq: GUTS) will present new preclinical obesity data from its Rejuva® platform at the American Diabetes Association's (ADA) 84th Scientific Sessions in Orlando, FL, on June 23, 2024. The study, titled "Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia after Semaglutide Withdrawal in a Murine Model of Obesity," has been selected as one of eight Presidents' Select abstracts. CEO Dr. Harith Rajagopalan will present the findings. Additionally, Fractyl will host an in-person Key Opinion Leader (KOL) event on June 24, 2024, featuring Dr. David A. D’Alessio from Duke University School of Medicine. The event will be webcast live for those unable to attend.
Fractyl Health presented preclinical data on its Rejuva GLP-1 pancreatic gene therapy at Digestive Disease Week 2024. The therapy showed significant reductions in liver weight (42%), liver triglycerides (67%), total cholesterol (36%), and LDL cholesterol (51%) compared to placebo two months post-administration. These results highlight the potential for profound metabolic benefits from a single administration. The company plans to nominate its first GLP-1 PGTx candidate for obesity in H2 2024. The therapy aims to address metabolic dysfunction-associated liver diseases such as MASLD and MASH, which are major causes of liver transplants in the U.S. Rejuva utilizes a proprietary delivery method to target the pancreas, aiming for durable effects on glucose and weight control.
Fractyl Health (Nasdaq: GUTS) announced its Q1 2024 financial results, highlighting several key developments and milestones. The company reported revenues from its pilot commercial launch in Germany but faced increased R&D and SG&A expenses, leading to a net loss of $3.3 million. However, this was a significant improvement from the $11.9 million loss in Q1 2023, primarily due to a $17.1 million non-cash gain.
Fractyl expects to initiate the Remain-1 pivotal study for weight maintenance in H2 2024 and anticipates topline data from the Revitalize-1 study in Q4 2024. The company is also progressing with its Rejuva gene therapy program, aiming to present new preclinical data in May 2024 and complete IND-enabling studies by H2 2024. Additionally, Fractyl appointed Adrian Kimber as Chief Commercial Officer to lead launch readiness for Revita.
Fractyl’s cash position as of March 31, 2024, was $121.4 million, which is expected to fund operations through 2025. The company will discuss these updates in a conference call on May 13, 2024.
Fractyl Health, Inc. presented promising 6-month follow-up data from its German real-world registry study of Revita for advanced Type 2 Diabetes (T2D). Participants showed sustained improvements in blood glucose, weight loss, and reduced T2D medication use after a single treatment. No serious adverse events related to the device or procedure have been reported. These results indicate the potential of Revita for durable weight loss maintenance.
Fractyl Health, Inc. (Nasdaq: GUTS) will present at BofA Securities 2024 Health Care Conference. Dr. Harith Rajagopalan, CEO, will participate in a fireside chat on May 15, 2024. The Company focuses on innovative treatments for obesity and type 2 diabetes.
Fractyl Health, Inc. (Nasdaq: GUTS) will report Q1 2024 financial results and business updates on May 13, 2024. The company focuses on metabolic therapeutics for obesity and T2D, hosting a conference call at 4:30 p.m. ET.
Fractyl Health, Inc. (Nasdaq: GUTS) will present new data at the German Diabetes Association (DDG) Annual Meeting on its real-world registry study of Revita for T2D and at the Digestive Disease Week (DDW) on the potential of Rejuva in reducing liver fat. The presentations include clinical updates and preclinical data demonstrating the effectiveness of their metabolic therapeutics in treating obesity and T2D.
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