Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs
Fractyl Health, Inc. (GUTS)
Company Research
Source: GlobeNewswire
Revita aims to be the first approved therapeutic option for durable weight maintenance after discontinuation of GLP-1 based drugs, as an adjunct to diet and exercise With this FDA IDE approval, Fractyl Health will initiate the Remain-1 randomized, double blind pivotal study and begin providing updates on the open label cohort, which we refer to as the Reveal-1 cohort, in the second half of 2024 BURLINGTON, Mass., April 01, 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 U.S. Food and Drug Administration (FDA) approval of a pivotal Investigational Device Exemption (IDE) to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist (GLP-1RA) drug therapy, addressing a key unmet need in the treatment of obesity. Obesity affects over 40% of the US population and is a c
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News
- Fractyl Health to Present at BofA Securities 2024 Health Care Conference [Yahoo! Finance]Yahoo! Finance
- Fractyl Health to Present at BofA Securities 2024 Health Care ConferenceGlobeNewswire
- Fractyl Health to Report First Quarter 2024 Financial Results and Provide Business Updates on May 13, 2024 [Yahoo! Finance]Yahoo! Finance
- Fractyl Health to Report First Quarter 2024 Financial Results and Provide Business Updates on May 13, 2024GlobeNewswire
- Fractyl Health, Inc.'s (NASDAQ:GUTS) largest shareholders are private equity firms with 52% ownership, individual investors own 30% [Yahoo! Finance]Yahoo! Finance
GUTS
Sec Filings
- 4/2/24 - Form 4
- 4/2/24 - Form 3
- 4/1/24 - Form 10-K
- GUTS's page on the SEC website