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. Throughout his career, he has showcased a commendable history of introducing groundbreaking therapies to worldwide markets. Renowned for his adeptness in formulating go-to-market strategies, assembling and leading commercial teams, and implementing operational excellence, he

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. "Sam Conaway's

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SC 13G - Fractyl Health, Inc. (0001572616) (Subject)

First-in-human study will evaluate safety, tolerability, and early efficacy of a one-time, pancreas-targeted smart GLP-1TM 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 pioneering pattern-breaking treatments for obesity and type 2 diabetes (T2D), today announced that it has submitted the first module of its Clinical Trial Application (CTA) in Europe for RJVA-001, the Company's gene therapy candidate from its Rejuva platform. RJVA-001 is de

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 gene therapy platform advancing toward first-in-human studies; first CTA module submission for RJVA-001 expected in June 2025 Conference call today at 4:30 p.m. ET BURLINGTON, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) ("the Company"),

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 be accessed in the "Events" section of Fractyl Health's website at http://ir.fractyl.com. The webcast will be archived and available for replay following the live event. The Company also announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Off

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 American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting, taking place May 13-17, 2025, in New Orleans, Louisiana. Oral Presentation Details: Title: Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibi

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 (T2D), today announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study. The results suggest that Revita, the Company's novel approach to targeting gut dysfunction, a root cause of obesity, may help prevent weight regain aft

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 in 2026 Conference call today at 4:30 p.m. ET BURLINGTON, Mass., March 03, 2025 (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 D

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 the conference call can be accessed in the "Events" section of Fractyl's website at https://ir.fractyl.com/. The webcast will be archived and available for replay following the live event. About Fractyl Health Fractyl Health is a metabolic therapeutics company foc

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 studies in H1 2025 Streamlined focus expected to extend cash runway into 2026 BURLINGTON, Mass., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering pattern breaking approaches for the

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 pattern breaking approaches for the treatment of obesity and type 2 diabetes (T2D), today announces promising initial clinical results from the first patient in the REVEAL-1 open-label cohort of the REMAIN-1 study one-month post GLP-1 drug discontinuation and Revi

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 of 2025 BURLINGTON, Mass., Dec. 12, 2024 (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), will present

Evercore ISI initiated coverage of Fractyl Health with a rating of Outperform

Morgan Stanley initiated coverage of Fractyl Health with a rating of Overweight and set a new price target of $18.00

BofA Securities initiated coverage of Fractyl Health with a rating of Buy and set a new price target of $26.00

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