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) presented new analysis from pooled data of Revita® clinical studies showing durable weight loss maintenance for one year. The analysis included 118 participants followed for 48 weeks post-Revita procedure. 90% of patients lost weight at one month, with 84% maintaining weight loss through one year without prescribed diet or lifestyle intervention. The study population had Type 2 Diabetes, with 62% having obesity and 34% being overweight. The Revita procedure, which resurfaces the duodenal lining, was well tolerated with no serious adverse events. The company expects to report pivotal trial data in Q4 2024.
Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focusing on obesity and Type 2 Diabetes treatments, has scheduled its third quarter 2024 financial results announcement and business updates for November 12, 2024, at 4:30 p.m. ET. The company will host a live webcast accessible through their investor relations website, with a replay option available after the event.
Fractyl Health (Nasdaq: GUTS) has announced upcoming presentations of weight maintenance data from its Revita and Rejuva platforms at ObesityWeek 2024, scheduled for November 2-6 in San Antonio, Texas. The company will showcase two key presentations:
1. An oral presentation on islet-targeted GLP-1 receptor agonist gene therapy's effects on fat reduction and metabolism improvement in obese mice, scheduled for November 5.
2. A poster presentation demonstrating how duodenal mucosal resurfacing maintains weight loss in metabolic disease, to be presented during the Welcome Reception on November 3.
These presentations highlight Fractyl Health's commitment to developing innovative treatments for obesity and Type 2 Diabetes by addressing their root causes.
Fractyl Health, Inc. (Nasdaq: GUTS), a metabolic therapeutics company focusing on new approaches to treat obesity and Type 2 Diabetes, has announced its participation in Chardan's 8th Annual Genetic Medicines Conference. The company's Co-founder and CEO, Harith Rajagopalan, M.D., Ph.D., will engage in a fireside chat on Tuesday, October 1, 2024, at 9:00 a.m. EDT.
Interested parties can register in advance for the presentation webcast. Following the live session, a replay will be available on the Events page of the Investors section on Fractyl Health's website at https://ir.fractyl.com/. This presentation offers an opportunity for investors and interested individuals to gain insights into Fractyl Health's innovative approaches in metabolic therapeutics.
Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focusing on obesity and Type 2 Diabetes treatments, has announced its participation in two upcoming investor conferences. Dr. Harith Rajagopalan, Co-founder and CEO, will represent the company at these events:
1. Morgan Stanley Global Healthcare Conference on 09/06/2024 at 10:45 AM ET (Fireside Chat format)
2. H.C. Wainwright 26th Annual Global Investment Conference on 09/09/2024 at 2:00 PM ET (Company Presentation format)
Webcast replays will be available on the company's investor relations website after the live sessions.
Fractyl Health (GUTS) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Updated clinical results from German Real-World Registry showing Revita®'s potential for sustained weight loss and blood sugar reduction for at least one year post-treatment.
2. FDA Breakthrough Device designation for Revita in weight maintenance after GLP-1 drug discontinuation.
3. Initiation of REMAIN-1 pivotal study for Revita in weight maintenance, with data readouts expected from Q4 2024.
4. REVITALIZE-1 study on track to report topline data in mid-2025 for an expanded Type 2 Diabetes patient population.
5. Presentation of preclinical data comparing Rejuva® to semaglutide at ADA 2024 Conference.
6. Q2 2024 financial results: R&D expenses $16.8M, SG&A expenses $6.2M, net loss $17.2M, cash position $102.4M.
Fractyl Health (Nasdaq: GUTS) announced promising clinical results from its German Real-World Registry for the Revita® endoscopic procedure. After 12 months, patients experienced:
- A median weight decrease from 111 kg to 97 kg (13% total body weight loss)
- A median HbA1c reduction from 9.6% to 7.2%
- Stable or decreased glucose-lowering medications in 10 out of 11 patients
The study involved 11 hard-to-treat patients with obesity and Type 2 Diabetes. Revita, designed to resurface the duodenal lining, shows potential as a durable weight maintenance solution. The procedure was well-tolerated with no reported adverse safety events.
Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focusing on innovative treatments for obesity and type 2 diabetes, has announced it will release its second quarter 2024 financial results and provide business updates on August 14, 2024, at 4:30 p.m. ET. The company will host a live webcast of the conference call, which can be accessed through the 'Events' section of Fractyl's investor relations website. For those unable to attend the live event, an archived version of the webcast will be made available for replay on the company's website.
Fractyl Health (Nasdaq: GUTS) has received FDA Breakthrough Device Designation for its Revita System in weight maintenance for people with obesity who discontinue GLP-1 drugs. Revita is an outpatient endoscopic procedure targeting the duodenal lining to potentially treat root causes of obesity and type 2 diabetes. The designation will enable priority FDA review upon completion of the REMAIN-1 study, with data readouts expected from Q4 2024.
Key points:
- Revita aims to address high discontinuation rates and substantial weight regain after stopping GLP-1 drugs
- Breakthrough status may accelerate development, assessment, and review processes
- Previous studies suggest potential for durable weight maintenance after a single Revita procedure
- Revita is already approved in Germany for T2D treatment
Fractyl Health will participate in the Piper Sandler 2nd Annual Virtual Obesity Day on June 26, 2024, at 9:30 a.m. EDT. CEO Dr. Harith Rajagopalan and CSO Dr. Timothy Kieffer will discuss recent corporate updates. Key highlights include the acceleration of their weight maintenance clinical study and compelling preclinical data from their Rejuva® pancreatic gene therapy. This data, presented at the American Diabetes Association’s 84th Scientific Session, demonstrated greater and more durable weight loss compared to semaglutide. Rejuva’s data was recognized as the top abstract out of 8,000 submissions. For more details and access to the webcast, please contact your Piper Sandler representative.
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