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Fractyl Health(GUTS) - 2024 Q2 - Quarterly Results
2024-08-14 20:05
Exhibit 99.1 Fractyl Health Reports Second Quarter 2024 Financial Results and Provides Business Updates 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 wit ...
Fractyl Health(GUTS) - 2024 Q2 - Quarterly Report
2024-08-14 20:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41942 Fractyl Health, Inc. (Exact Name of Registrant as Specifie ...
Fractyl Health Receives FDA Breakthrough Device Designation for Revita in Weight Maintenance for People with Obesity Who Discontinue GLP-1 Based Drugs
Newsfilter· 2024-07-30 11:00
Breakthrough Device Designations are granted by the U.S. FDA to expedite review of promising technologies that address high unmet needs and may improve the lives of people with life-threatening or debilitating conditions BURLINGTON, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- 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 the U.S. Food and Drug Administ ...
Fractyl Health(GUTS) - 2024 Q1 - Earnings Call Transcript
2024-05-14 02:37
Fractyl Health, Inc. (NASDAQ:GUTS) Q1 2024 Earnings Conference Call May 13, 2024 4:30 PM ET Company Participants Stephen Jasper - Gilmartin Group Harith Rajagopalan - Co-founder and CEO Lisa Davidson - CFO Timothy Kieffer - Chief Scientific Officer Adrian Kimber - Chief Commercial Officer Conference Call Participants Michael DiFiore - Evercore ISI Michael Ulz - Morgan Stanley Operator Good afternoon, and welcome to Fractyl Health's First Quarter Financial Results and Business Updates Call. As a reminder, th ...
Fractyl Health(GUTS) - 2024 Q1 - Quarterly Report
2024-05-13 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-41942 Fractyl Health, Inc. (Exact Name of Registrant as Specified in its Charter) (State ...
Fractyl Health(GUTS) - 2024 Q1 - Quarterly Results
2024-05-13 20:01
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 Exhibit 99.1 Fractyl Health Reports First Quarter 2024 Financial Results and Provides Business Updates Appointed Adrian ...
Fractyl Health(GUTS) - 2023 Q4 - Annual Report
2024-04-01 11:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41942 Fractyl Health, Inc. (Exact name of Registrant as specified in its Charter) Delaware 27-3553477 (State or ot ...
Fractyl Health(GUTS) - 2023 Q4 - Annual Results
2024-04-01 11:10
Announced nomination of RJVA-001 as first clinical candidate in the Rejuva® GLP-1 gene therapy platform; completion of IND- enabling studies expected in second half of 2024 Completed initial public of ering of common stock raising $110 million in gross proceeds; cash on hand expected to fund operations through 2025 BURLINGTON, MA, April 1, 2024 (GLOBENEWSWIRE) – Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and ...