GUTS - Earnings announcements

Completed randomization in REMAIN-1 Pivotal Cohort; topline 6-Month data expected in early Q4 2026 Received favorable FDA feedback on De Novo classification request; De Novo submission expected in late Q4 2026 Reports new post-hoc analyses from REMAIN-1 Midpoint Cohort showing statistically significant ablation-length (i.e., dose)-dependent treatment effect on post-GLP-1 weight maintenance at 6 months Patients with greater GLP-1-induced weight loss prior to randomization also exhibited larger sham-adjusted treatment effects at 6 months, with effect size increasing over time New analyses provide further support for Revita mechanism of action and REMAIN-1 Pivotal Cohort design Reiterates

BURLINGTON, Mass., March 17, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced that it will report financial results for the fourth quarter and full year 2025 and provide business updates on Tuesday, March 24, 2026, at 4:30 p.m. ET. A live webcast of the conference call and presentation 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. About Fractyl Health         Fractyl Health is a clinical stage met

Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months Results support pivotal study design and further substantiate Revita's potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6-month pivotal data and potential FDA filing expected in H2 2026 Based on ongoing interactions and favorable safety data to date, the Company has requested FDA feedback on reclassifying

BURLINGTON, Mass., Nov. 05, 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 it will report financial results for the third quarter 2025 and provide business updates on Wednesday, November 12, 2025, at 4:30 p.m. ET. A live webcast of the conference call and presentation 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. About Fractyl Health Fractyl Health is a metabolic therapeutics company f

BURLINGTON, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company" or "Fractyl"), 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 second quarter 2025 and provide business updates on Tuesday, August 12, 2025, at 4:30 p.m. ET. The Company also announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health, will present at the Canaccord Genuity 45th Annual Growth Conference on Wednesday, August 13, 2025, at 11:30 a.m. ET. A live webcast of the conference call and presentatio

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

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

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 BURLINGTON, Mass, Nov. 12, 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 reported its third quarter 2024 finan

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 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 focused on pioneeri

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 readouts beginning in Q4 2024 REVITALIZE-1 on-track to report topline data in mid-2025 in expanded Type 2 Diabetes patient population Presented head-to-head preclinical data comparing Rejuva® versus semaglutide in #1 abstract at ADA 2024 Conference call today at 4:30

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 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 focused on pioneering new

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 Commercial Officer to lead Revita launch readiness activities Conference call today at 4:30 p.m. ET BURLINGTON, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new appro

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. A live webcast of the conference call can be accessed in the "Events" section of Fractyl's website at www.ir.fractyl.com. The webcast will be archived and available for replay following the live event. About Fractyl Healt