GUTS

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

4 - FRACTYL HEALTH, INC. (0001572616) (Issuer)

3 - FRACTYL HEALTH, INC. (0001572616) (Issuer)

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

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

BURLINGTON, Mass., Jan. 06, 2026 (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 the appointment of Lara Smith Weber as Chief Financial Officer, effective January 12, 2026. Ms. Smith Weber will oversee finance, accounting, and investor relations; and will serve as a key strategic partner to the Company's executive leadership team and Board of Directors. Ms. Smith Weber brings more than 20 years of financial leadership experience across medtech, biotech, and other growth-oriented industries. She has a str

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

Randomized 6-month data from the REMAIN-1 Midpoint Cohort expected in late January 2026 Topline 6-month data from the REMAIN-1 Pivotal Cohort and potential PMA submission expected in H2 2026 Approximately $85.6 million in cash and cash equivalents on hand, supporting execution across planned 2026 milestones Received gross proceeds of $23.0 million from exercises of Tranche A warrants from August 2025 financing, with cash runway into early 2027 BURLINGTON, Mass., Jan. 05, 2026 (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)

4 - FRACTYL HEALTH, INC. (0001572616) (Issuer)

4 - FRACTYL HEALTH, INC. (0001572616) (Issuer)

4 - FRACTYL HEALTH, INC. (0001572616) (Issuer)

BURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company" or "Fractyl"), a metabolic therapeutics company focused on pioneering pattern-breaking approaches that treat root causes of obesity and type 2 diabetes ("T2D"), today announced that it will call all of its outstanding Tranche A Common Stock Purchase Warrants (the "Tranche A Warrants") to purchase shares of the Company's common stock, par value $0.00001 per share (the "Common Stock") for cancellation for cash consideration of $0.00001 per underlying share at 6:30 p.m., New York City time, on December 30, 2025 (the "Cancellation Date"). The Tranche A Warrants were issued in connection with

4 - FRACTYL HEALTH, INC. (0001572616) (Issuer)

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