SEC Form 10-Q filed by Fractyl Health Inc.
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Date | Price Target | Rating | Analyst |
---|---|---|---|
2/28/2024 | Outperform | Evercore ISI | |
2/27/2024 | $18.00 | Overweight | Morgan Stanley |
2/27/2024 | $26.00 | Buy | BofA Securities |
144 - FRACTYL HEALTH, INC. (0001572616) (Subject)
8-K - FRACTYL HEALTH, INC. (0001572616) (Filer)
10-Q - FRACTYL HEALTH, INC. (0001572616) (Filer)
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
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
Fractyl Health, Inc. (NASDAQ:GUTS) (the "Company"), a metabolic therapeutics company focused on pioneering new approaches that treat the root cause of obesity and type 2 diabetes (T2D), today announced that it will accelerate its REMAIN-1 clinical study, which is evaluating Revita's efficacy in maintaining weight loss following the discontinuation of GLP-1 therapy. The Company also announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to the protocol for the REVITALIZE-1 study of its Revita device, which expands eligibility to patients with T2D who are inadequately controlled on any glucose lowering agent, including GLP-1 agonists and/or insulin, thus expanding
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 presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)'s 84th Scientific Sessions in Orlando, FL. The presentation titled "Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity," and was chosen as noteworthy and one of eight President's Select Abstracts at ADA this year. Rejuva is the Company's adeno-associated virus (AAV)
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 presented new data from its preclinical Rejuva pancreatic gene therapy program in an oral presentation at the American Diabetes Association (ADA)'s 84th Scientific Sessions in Orlando, FL. The presentation titled "Single-Dose GLP-1-Based Pancreatic Gene Therapy Durably Maintains Body Composition and Glycemia After Semaglutide Withdrawal in a Murine Model of Obesity," and was chosen as noteworthy and one of eight President's Select Abstracts at ADA this year. Single administration of Rejuva reduced fat mass and
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
4 - FRACTYL HEALTH, INC. (0001572616) (Issuer)
3/A - FRACTYL HEALTH, INC. (0001572616) (Issuer)
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SC 13G - Fractyl Health, Inc. (0001572616) (Subject)
BURLINGTON, Mass., Sept. 03, 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 that Harith Rajagopalan, M.D., Ph.D., Co-founder and Chief Executive Officer of the Company, will present at two upcoming investor conferences. Details of the presentations can be found below. Morgan Stanley Global Healthcare Conference Format: Fireside Chat Date: 09/06/2024 Time: 10:45 AM ET H.C. Wainwright 26th Annual Global Investment Conference Format: Company Presentation Date: 09/09/2024 Time: 2:00 PM ET Webcast replays will
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
Median weight decreased from 111 kilograms (245 pounds) to 97 kilograms (214 pounds), representing nearly 13% total body weight loss at 12 months in a hard-to-treat patient population living with obesity and Type 2 Diabetes Median HbA1c also decreased substantially from 9.6% to 7.2% at 12 months in these individuals who remained poorly controlled despite multiple glucose-lowering medications and advanced T2D Real-world results demonstrate potential for Revita to meaningfully sustain weight loss and lower blood sugar for at least one-year post-treatment Additional registry data from a larger number of patients will be presented at a scientific congress later this year BURLINGTON, Mass., A