Articles from Fractyl Health, Inc.

Strong patient and physician demand for pivotal REMAIN-1 study highlights urgent need for post-GLP-1 withdrawal weight maintenance solutions; midpoint data analysis anticipated in Q2 2025 and full study enrollment expected in summer 2025

BURLINGTON, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern breaking approaches for the treatment of obesity and type 2 diabetes (T2D), today announced it will report financial results for the fourth quarter and full year 2024 and provide business updates on Monday, March 3, 2025, at 4:30 p.m. ET.

Prioritizing Revita’s clinical development on weight maintenance post-GLP-1 withdrawal in response to significant patient and physician demand in ongoing REMAIN-1 pivotal study; anticipate midpoint data analysis in Q2 2025 and full pivotal study enrollment in summer 2025

Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study

RJVA-001 was successfully delivered in large animal Yucatan pig models at low total viral dose

BURLINGTON, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today 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) taking place December 12-14, 2024.

BURLINGTON, Mass., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will present at two upcoming investor conferences.

REMAIN-1 weight maintenance pivotal study enrollment progressing rapidly; mid-point data analysis expected in Q2 2025

13-week follow-up represents the longest data to-date demonstrating durable efficacy of RJVA-001 on weight and blood sugar in the diet-induced obesity (DIO) mouse model

Single Revita procedure led to sustained, clinically meaningful weight loss in majority of patients with Type 2 Diabetes

BURLINGTON, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced it will report financial results for the third quarter 2024 and provide business updates on Tuesday, November 12, 2024, at 4:30 p.m. ET.

BURLINGTON, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that it will present compelling weight maintenance data from both its Revita and Rejuva platforms at The Obesity Society’s Annual Meeting at ObesityWeek 2024, held from November 2-6, 2024, in San Antonio, Texas.

BURLINGTON, Mass., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D)), today announced that Harith Rajagopalan, M.D., Ph.D., Co-founder and Chief Executive Officer of Fractyl Health, will participate in a fireside chat at Chardan’s 8th Annual Genetic Medicines Conference on Tuesday, October 1, 2024, at 9:00 a.m. EDT.

BURLINGTON, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and Type 2 Diabetes (T2D), today announced that Harith Rajagopalan, M.D., Ph.D., Co-founder and Chief Executive Officer of the Company, will present at two upcoming investor conferences.

Updated clinical results from German Real-World Registry demonstrate potential for Revita® to meaningfully sustain weight loss and lower blood sugar for at least one-year post-treatment in a real-world setting

Median weight decreased from 111 kilograms (245 pounds) to 97 kilograms (214 pounds), representing nearly 13% total body weight loss at 12 months in a hard-to-treat patient population living with obesity and Type 2 Diabetes

BURLINGTON, Mass., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced it will report financial results for the second quarter 2024 and provide business updates on Wednesday, August 14, 2024, at 4:30 p.m. ET.

Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising technologies that address high unmet needs and may improve the lives of people with life-threatening or debilitating conditions

Company will discuss recent corporate updates, including compelling preclinical data from Rejuva® pancreatic gene therapy platform, which was named top abstract at American Diabetes Association’s 84th Scientific Session

Company will accelerate Revita® weight maintenance clinical study REMAIN-1; open label data from REVEAL-1 cohort expected in Q4 2024 and mid-point data analysis for REMAIN-1 anticipated in Q2 2025

Single administration of Rejuva reduced fat mass and improved glycemia in the well-validated diet-induced obesity (DIO) mouse model

Management to host in-person KOL event and webcast at ADA on Monday, June 24, 2024, at 7:00 a.m. ET

Results showed single-administration GLP-1 pancreatic gene therapy candidate reduced liver weight by 42% (p<0.01) and liver triglycerides by 67% (p<0.0001) compared to placebo two months after administration

Initiation of Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 based drugs expected in the second half of 2024

First 14 participants with at least six months of follow up continue to demonstrate sustained improvements in blood glucose and weight with reduction in T2D medication utilization after a single Revita treatment

BURLINGTON, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced that Dr. Harith Rajagopalan, CEO of Fractyl Health, will participate in a fireside chat at the upcoming BofA Securities 2024 Health Care Conference on Wednesday, May 15, 2024, at 4:20 p.m. PDT (7:20 p.m. EDT).

BURLINGTON, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced it will report financial results for the first quarter 2024 and provide business updates after market close on Monday, May 13, 2024. The Company’s management will host a conference call on the same day beginning at 4:30 p.m. ET.

At DDG, Fractyl Health will present new clinical updates on its ongoing real-world registry study of Revita® in patients with T2D in Germany

BURLINGTON, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced the appointment of Adrian Kimber as Chief Commercial Officer.

Received IDE approval for the Revita® Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 Based Drugs

Revita aims to be the first approved therapeutic option for durable weight maintenance after discontinuation of GLP-1 based drugs, as an adjunct to diet and exercise

Data provides first demonstration of glucose lowering and weight loss potency from pancreas-produced native human GLP-1, highlighting the capacity of pancreatic GLP-1 to provide metabolic control.

Data provides first demonstration of glucose lowering and weight loss potency from pancreas-produced native human GLP-1, highlighting the capacity of pancreatic GLP-1 to provide metabolic control.

LEXINGTON, Mass., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“Fractyl Health” or the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of Type 2 Diabetes (T2D) and obesity, today announced the appointment of Samuel Conaway to its Board of Directors. Mr. Conaway's extensive background in the commercialization of medical technologies and leadership in new product launches will provide valuable insight and experience as Fractyl Health advances through pivotal clinical studies for T2D and weight loss maintenance and continues its ongoing pilot launch and real-world registry study of Revita in Germany.

LEXINGTON, Mass., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today announced the pricing of its initial public offering of 7,333,333 shares of common stock at a public offering price of $15.00 per share, for total gross proceeds of approximately $110.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Fractyl Health. All of the common stock is being offered by Fractyl Health. The offering is expected to close on February 6, 2024, subject to customary closing conditions. In addition, Fractyl Health has granted the underwriters a 30-day option to purchase up to an additional 1,099,999 shares of its common stock at the initial public offering price less the underwriting discounts and commissions.

RJVA-001 is the first GLP-1 pancreatic gene therapy (GLP1 PGTx) candidate to be nominated by the Company and is designed to improve upon known issues of treatment discontinuation and metabolic rebound typically seen with existing GLP-1 based therapies

A single Revita endoscopic procedure resulted in 3.4% mean total body weight loss by Week 4 in patients with advanced T2D that was maintained to 4% mean total body weight loss through Week 48 in the absence of any active ongoing diet or lifestyle intervention

Single administration GLP-1 PGTx resulted in 27% total body weight loss at Day 28 compared to 21% for chronic semaglutide 10 nmol/kg/day in the Diet-Induced Obesity (DIO) rodent model

LEXINGTON, Mass., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Fractyl Health, a metabolic therapeutics company focused on pioneering new approaches to the treatment of type 2 diabetes (T2D) and obesity, today announced the expansion of an academic-industry scientific partnership charged with advancing research on the role of the gut and pancreas in metabolic disease. The new research, to be led by Professor Randy Seeley, Ph.D., of Michigan Medicine, is intended to explore the mechanistic rationale underlying the use of local pancreatic gene therapy to produce targeted treatment options that address, and hopefully remit, metabolic diseases.