Fractyl Health Shares Rise 40% After FDA Approval of IDE for Revita

By Chris Wack

Fractyl Health shares were up 40% to $10.39 in premarket trading after the company received U.S. Food and Drug Administration approval of a pivotal Investigational Device Exemption to study Revita.

The company said the goal of the study is seeing Revita's efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist drug therapy, a treatment of obesity.

The IDE approval launches the study, set to begin in the second half of 2024, in patients who have lost at least 15% total body weight on tirzepatide therapy. It is designed to be a pivotal study to potentially enable registrational filing for Revita for weight maintenance after GLP-1RA discontinuation.

Fractyl Health is also planning an open-label cohort that will follow a similar patient population and management protocol with anticipated open-label data updates as the study progresses. The rationale for this new study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy.

Revita is an outpatient endoscopic procedure that targets the duodenum and is designed to reverse pathology in the duodenal lining that is a root cause of obesity and type 2 diabetes.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

April 01, 2024 06:33 ET (10:33 GMT)

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