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

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

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

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

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

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

SCHEDULE 13G - 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)

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

H.C. Wainwright initiated coverage of Fractyl Health with a rating of Buy and set a new price target of $9.00

Ladenburg Thalmann initiated coverage of Fractyl Health with a rating of Buy and set a new price target of $3.60

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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., 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

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)

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

Participants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 discontinuation and single Revita treatment 1.5% mean weight change observed with Revita (n=17); published third-party studies after GLP-1 withdrawal alone have shown ~10% weight regain at similar time points Upcoming randomized 6-month REMAIN-1 Midpoint Cohort data expected in January 2026; topline 6-month Pivotal Cohort data and potential PMA filing anticipated in H2 2026 BURLINGTON, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pioneering pattern-breaking approaches

BURLINGTON, Mass., Dec. 01, 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 that Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of the Company, will be participating in a fireside chat at the 8th Annual Evercore Healthcare Conference, being held December 2-4, 2025, in Coral Gables, FL. 8th Annual Evercore Conference Format: Fireside chat and one-on-one meetings Date: 12/03/2025 Time: 1:45 PM ET A webcast replay will be accessible following the live session on the Events page o

Positive randomized 3-month REMAIN-1 Midpoint Cohort data showed single Revita procedure maintained weight loss after GLP-1 discontinuation; 6-month data expected in Q1 2026 6-month data from open-label REVEAL-1 Cohort expected in Q4 2025 Topline 6-month data from REMAIN-1 Pivotal Cohort and potential PMA filing expected in H2 2026 $83M in underwritten offerings expected to extend cash runway through upcoming clinical and regulatory milestones and into early 2027 Conference call today at 4:30 p.m. ET BURLINGTON, Mass., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (NASDAQ:GUTS) (the Company or Fractyl), a metabolic therapeutics company focused on pattern-breaking approaches

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

RJVA-002 achieved ~30% weight loss at five weeks in a translational obesity model; weight loss not yet plateauedPreclinical results show that a single point-in-time treatment with RJVA-002 has the potential to achieve significant weight loss that can match or exceed best-in-class chronic drug therapy BURLINGTON, Mass., Oct. 07, 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 potent new preclinical data from RJVA-002, the second candidate from the Company's Rejuva® Smart GLP-1™ platform, at the 2025 Cell & Gene Mee

Fractyl Health Announces Pricing of $60 Million Underwritten Offering of Common Stock BURLINGTON, Mass., September 26, 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 the pricing of an underwritten offering of 60 million shares of its common stock at a price of $1.00 per share. All of the securities are being offered by Fractyl. The gross proceeds from the offering to Fractyl are expected to be approximately $60 million, before deducting underwriting discounts and commissions and other offering ex

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

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

SC 13G - FRACTYL HEALTH, INC. (0001572616) (Subject)

SC 13G - FRACTYL HEALTH, INC. (0001572616) (Subject)

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