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, Inc. (Nasdaq: GUTS) is a pioneering metabolic therapeutics company based in Burlington, MA, dedicated to transforming the treatment of metabolic diseases such as type 2 diabetes (T2D) and obesity. The company aims to shift the paradigm from chronic symptomatic management to durable disease-modifying therapies that address the root causes of these conditions at the organ level.
Fractyl Health's leading product candidate, Revita®, focuses on remodeling the duodenal lining through hydrothermal ablation, known as duodenal mucosal resurfacing (DMR). This innovative approach aims to correct abnormal intestinal nutrient sensing and signaling mechanisms, which are potential root causes of metabolic diseases like T2D and obesity. Revita has received a CE mark in Europe and reimbursement authorization in Germany for T2D treatment. In the United States, Revita is for investigational use only. The company is currently enrolling patients in pivotal studies such as Revitalize-1 and Remain-1 to further investigate the efficacy of Revita.
Additionally, Fractyl Health's Rejuva® platform is in the preclinical development stage, focusing on next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies. The platform aims to offer novel, disease-modifying therapies that target the pancreas, leveraging advanced delivery systems and proprietary screening methods.
Recently, Fractyl Health presented new preclinical data from its Rejuva platform at the Digestive Disease Week (DDW) 2024, showcasing the potential of GLP-1 based pancreatic gene therapy to reduce liver fat in diet-induced obesity models. The company also shared impressive 6-month follow-up data from its German real-world registry study of Revita for T2D, highlighting significant improvements in blood sugar levels, body weight, and medication burden among participants.
Fractyl Health continues to advance its mission with promising research and active participation in major medical conferences. The company’s strategic goals include progressing towards regulatory approvals and expanding clinical studies to validate their innovative therapies.
For more information, visit www.fractyl.com or follow Fractyl Health on Twitter.
Fractyl Health (NASDAQ: GUTS) presented promising preclinical data for RJVA-001, their Rejuva® Smart GLP-1™ pancreatic gene therapy, at WCIRDC. The study demonstrated successful delivery in Yucatan pig models using an endoscopic ultrasound-guided system. Key findings include:
- Achieved therapeutically relevant GLP-1 expression in pancreatic beta cells at low viral doses (6e13 vg per pig)
- Expression levels were five times higher in treated vs untreated animals (p< 0.02)
- No adverse safety effects observed
- Pancreatic lipase remained in normal range
The company plans to initiate first-in-human studies in the first half of 2025. Previous mouse studies showed RJVA-001's potential to maintain improvements in weight and blood glucose levels after discontinuing semaglutide treatment.
Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company, announced it will present new preclinical data from its Rejuva® platform at the 2024 Poster Session of the 22nd World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC). The presentation will focus on the feasibility and safety of novel endoscopic ultrasound-guided delivery of human GLP-1 pancreatic gene therapy in pigs. The session is scheduled for December 12, 2024, from 6:30 pm to 7:30 pm (PST).
The company specializes in developing new approaches to treat root causes of obesity and Type 2 Diabetes (T2D) through their single-administration Smart GLP-1 Pancreatic Gene Therapy Platform.
Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company specializing in obesity and Type 2 Diabetes treatments, has announced its participation in two upcoming investor conferences. The company's Co-Founder and CEO, Harith Rajagopalan, M.D., Ph.D., will present at:
- The 7th Annual Evercore ISI HealthCONx Conference (Fireside Chat) on December 3, 2024, at 7:30 AM ET
- The Piper Sandler 36th Annual Healthcare Conference (Fireside Chat) on December 4, 2024, at 1:30 PM ET
Webcast replays will be available on the company's investor relations website.
Fractyl Health reported Q3 2024 financial results, highlighting progress in its obesity and Type 2 Diabetes treatments. The company's REMAIN-1 weight maintenance study is advancing rapidly, with mid-point analysis expected in Q2 2025. Revenue was generated from German commercial launch, while R&D expenses increased to $19.0M from $9.4M year-over-year. Net loss widened to $23.2M from $15.7M. The company maintains $84.7M in cash, expected to fund operations through Q4 2025.
Key developments include the nomination of RJVA-002, a smart GIP/GLP-1 pancreatic gene therapy candidate for obesity treatment, and plans to initiate first-in-human studies for RJVA-001 in H1 2025, pending CTA approval.
Fractyl Health (GUTS) presented new preclinical data for its Rejuva RJVA-001 single-administration GLP-1 pancreatic gene therapy candidate. The 13-week study in diet-induced obesity mice showed sustained weight maintenance and blood sugar control, with over 10% of islet cells expressing GLP-1 protein and no safety concerns. The company also announced RJVA-002, a GIP/GLP-1 dual agonist, as its first pancreatic gene therapy candidate for obesity. This AAV9 viral vector expresses human GIP and GLP-1 hormones from a human insulin promoter, targeting both receptors important for blood sugar and weight regulation.
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.
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