GUTS

8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

Participants retained ~78% of GLP-1 induced total body weight loss one year after discontinuation and a single Revita procedure 5.3% mean weight change observed with Revita (n=15); published third-party studies after GLP-1 withdrawal alone have shown ~15% weight regain at similar time points 33% of patients continued to lose further weight one year after discontinuing a GLP-1 Next anticipated Revita® clinical data readouts are one-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 and topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 BURLINGTON, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or

BURLINGTON, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced the appointment of Mike Zumdahl as Senior Vice President, Market Access and Commercial Strategy. Mr. Zumdahl served as Vice President of Global Health Economics, Market Access, and Government Affairs at Inari Medical, where he led the function through the company's growth and 2025 acquisition by Stryker. He joins Fractyl as the Company prepares for the anticipated REMAIN-1 Pivotal Cohort topline readout in early Q4 2026 and a potenti

SCHEDULE 13G/A - FRACTYL HEALTH, INC. (0001572616) (Subject)

SCHEDULE 13G/A - FRACTYL HEALTH, INC. (0001572616) (Subject)

10-Q - FRACTYL HEALTH, INC. (0001572616) (Filer)

8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

Next anticipated Revita® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for potential FDA De Novo marketing application submission in post-GLP-1 weight maintenance reaffirmed Clinical Trial Application authorization of RJVA-001 first-in-human study in the Netherlands for T2D; first-in-human dosing anticipated in second half of 2026 reiterated Cash runway guidance into early 2027, beyond anticipated Pivotal data readout reiterated Conference call today at 4:30 p.m. ET BURLINGTO

8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita® in pivotal development for post-GLP-1 weight maintenance and Rejuva® entering first-in-human studies for type 2 diabetes First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation Rejuva® clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans BURLINGTON, Mass., May 11, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and typ

BURLINGTON, Mass., May 05, 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 (T2D), today announced that it will report financial results for the first quarter 2026 and provide business updates on Tuesday, May 12, 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. The Company also announced that Harith Rajagopalan, M.D., Ph.D., Co-Founder and C

DEFA14A - FRACTYL HEALTH, INC. (0001572616) (Filer)

DEF 14A - FRACTYL HEALTH, INC. (0001572616) (Filer)

10-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

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

8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

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

8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

Topline 6-month pivotal data expected in early Q4 2026 with potential FDA marketing application submission expected in late Q4 2026 Company reiterates cash runway guidance into early 2027, beyond anticipated pivotal data readout BURLINGTON, Mass., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a clinical stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes, today announced completion of participant randomization in its REMAIN-1 Pivotal Cohort, a double-blind, sham-controlled study evaluating Revita® for weight maintenance following GLP-1 therapy discontinuation. "Completion

SCHEDULE 13G/A - FRACTYL HEALTH, INC. (0001572616) (Subject)

SCHEDULE 13G/A - FRACTYL HEALTH, INC. (0001572616) (Subject)

Morgan Stanley downgraded Fractyl Health from Overweight to Equal-Weight and set a new price target of $2.00

8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)

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