First-in-human study will evaluate safety, tolerability, and early efficacy of a one-time, pancreas-targeted smart GLP-1 TM gene therapy for patients with inadequately controlled T2D and obesity Expect to dose first patients and report preliminary data in 2026, pending CTA authorization BURLINGTON, Mass., May 19, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company... Read More

Data suggests that single dose of RJVA-001 leads to durable metabolic improvements with low systemic GLP-1 exposure in db/db mouse model of T2D— potentially simultaneously addressing durability, adherence, and tolerability challenges seen with current GLP-1 drugs Endoscopic ultrasound-guided delivery achieves targeted pancreatic expression in a large animal model with no toxicity observed to date Data show... Read More

REVEAL-1 Cohort 3-month open-label data update expected in June 2025; early clinical signals reinforce Revita’s potential to maintain weight loss after GLP-1 discontinuation in the real world REMAIN-1 Midpoint Cohort data expected in Q3 2025; first randomized data on post-GLP-1 weight maintenance REMAIN-1 Pivotal Cohort has completed enrollment ahead of schedule; 6-month primary endpoint data anticipated in H2 2026 Rejuva... Read More

BURLINGTON, Mass., May 06, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced it will report financial results for the first quarter 2025 and provide business updates on Tuesday, May 13, 2025, at 4:30 p.m. ET. A live webcast of the conference call can... Read More

BURLINGTON, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced that it will deliver an oral presentation of compelling preclinical data from its Rejuva single-administration Smart GLP-1 pancreatic gene therapy platform at the... Read More

New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes... Read More

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 Company plans to submit first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators in H1 2025, and if CTA is authorized, expects to report preliminary data... Read More

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. A live webcast of... Read More

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 RJVA-001, first clinical candidate in Rejuva gene therapy program, has completed key preclinical in vivo studies; on-track to initiate first-in-human... Read More

Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discontinuation; mid-point analysis on-track and anticipated in Q2 2025 BURLINGTON, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering... Read More

RJVA-001 was successfully delivered in large animal Yucatan pig models at low total viral dose Results confirm ability to directly target pancreas with novel delivery catheter and route of administration Local delivery of RJVA-001 achieved therapeutically relevant GLP-1 expression within pancreatic beta cells with no adverse safety effects observed Company plans to initiate first-in-human studies with RJVA-001 in first half... Read More

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 22 nd World Congress Insulin Resistance, Diabetes & Cardiovascular Disease... Read More

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. Details of the presentations... Read More

REMAIN-1 weight maintenance pivotal study enrollment progressing rapidly; mid-point data analysis expected in Q2 2025 Anticipate reporting data from REVEAL-1 open-label cohort beginning in Q4 2024 Topline data from REVITALIZE-1 pivotal study expected in mid-2025 Company presented compelling weight maintenance data from both Revita ® and Rejuva ® platforms at ObesityWeek ® 2024 Conference call today at 4:30 p.m. ET... Read More

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 Company plans to use durable efficacy results as part of its FIH data package for RJVA-001 Fractyl also announces the nomination of RJVA-002, a GIP/GLP-1 dual agonist, as its first pancreatic gene therapy candidate for obesity BURLINGTON, Mass., Nov. 04, 2024... Read More

Single Revita procedure led to sustained, clinically meaningful weight loss in majority of patients with Type 2 Diabetes REMAIN-1 weight maintenance pivotal study on-track to report mid-point data analysis in Q2 2025 Company will report weight maintenance data after discontinuation of GLP-1 drugs in open-label REVEAL-1 cohort in Q4 2024 BURLINGTON, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS)... Read More

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. A live webcast of the conference call... Read More

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... Read More

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 8 th Annual Genetic... Read More

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. Details of the presentations... Read More

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 Granted U.S. FDA Breakthrough Device designation for Revita in weight maintenance after discontinuation of GLP-1 based drugs REMAIN-1 pivotal study for Revita in weight maintenance now initiated with anticipated data... Read More

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 Median HbA1c also decreased substantially from 9.6% to 7.2% at 12 months in these individuals who remained poorly controlled despite multiple glucose-lowering medications and advanced T2D Real-world... Read More

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. A live webcast of the conference call... Read More

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 REMAIN-1 pivotal study underway to accelerate pathway for weight maintenance indication for Revita®, with anticipated data readouts beginning in Q4 2024 BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) --... Read More

BURLINGTON, Mass., June 25, 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, and Dr. Timothy Kieffer, CSO of Fractyl Health, will participate in a virtual fireside chat at the upcoming Piper Sandler 2 nd... Read More

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 Company expands Revita type 2 diabetes clinical study REVITALIZE-1, expanding eligibility; increases potential U.S. treatment population for Revita by over 6x (from ~4 to ~25 million patients) Company presented preclinical data... Read More

Single administration of Rejuva reduced fat mass and improved glycemia in the well-validated diet-induced obesity (DIO) mouse model Rejuva also prevented weight and glycemic rebound after semaglutide withdrawal Data provide first demonstration that Rejuva treatment has potential to mimic natural release of GLP-1 from pancreas BURLINGTON, Mass., June 23, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the... Read More

BURLINGTON, Mass., May 29, 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 it will present new preclinical obesity data from its pancreatic gene therapy platform, Rejuva, at the upcoming American Diabetes Association (ADA)’s 84 th Scientific Sessions... Read More

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 Data also demonstrated reductions of 36% in total cholesterol and 51% in low density lipoprotein (LDL) cholesterol (both, p<0.0001) compared to placebo two months after administration New results highlight potential for... Read More

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 Topline data from Revitalize-1 pivotal study in patients with inadequately controlled T2D anticipated in the fourth quarter 2024 Update from real-world Germany registry study of Revita in patients with T2D at DDG Annual Meeting Appointed Adrian Kimber as Chief... Read More

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 No device- or procedure-related serious adverse events have been observed to date in any registry participant BURLINGTON, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a... Read More

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... Read More

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... Read More

At DDG, Fractyl Health will present new clinical updates on its ongoing real-world registry study of Revita ® in patients with T2D in Germany At DDW, Fractyl Health will provide an oral presentation from its Rejuva ® platform with new preclinical data demonstrating the potential of GLP-1 based pancreatic gene therapy (GLP-1 PGTx) to durably reduce liver fat in the diet-induced obesity model BURLINGTON, Mass., April 30, 2024... Read More

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. Mr. Kimber joins Fractyl with over two decades of experience in the biotechnology and medical devices sectors.... Read More

Received IDE approval for the Revita® Remain-1 pivotal study for weight maintenance in patients with obesity after discontinuation of GLP-1 Based Drugs Completion of enrollment in pivotal Revitalize-1 study in patients with inadequately controlled T2D expected in second quarter of 2024 and anticipated topline data in fourth quarter of 2024 Announced nomination of RJVA-001 as first clinical candidate in the Rejuva® GLP-1 gene... Read More

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 With this FDA IDE approval, Fractyl Health will initiate the Remain-1 randomized, double blind pivotal study and begin providing updates on the open label cohort, which we refer to as the Reveal-1 cohort, in the second half of 2024 BURLINGTON, Mass., April 01,... Read More

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. The human GLP-1 transgene sequence used in RJVA-001 was administered to eight-week-old db/db mice with established disease and resulted in up to 50% blood sugar lowering and 11% weight loss vs vehicle at four weeks after a single... Read More

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. The human GLP-1 transgene sequence used in RJVA-001 was administered to eight-week-old db/db mice with established disease and resulted in up to 50% blood sugar lowering and 11% weight loss vs vehicle at four weeks after a single... Read More

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... Read More