Edgewise Shares Rise Premarket on FDA Fast-Track Designation

By Colin Kellaher

Edgewise Therapeutics shares moved higher in premarket trading Tuesday after the clinical-stage biopharmaceutical company won U.S. Food and Drug Administration fast-track designation for EDG-5506 for the treatment of Duchenne muscular dystrophy.

Shares, which closed Monday at $18.95, were recently up 7.9% to $20.45 in premarket trading.

The Boulder, Colo., company on Tuesday said it is currently conducting a pair of Phase 2 placebo-controlled studies of EDG-5506 in Duchenne, a severe, degenerative muscle disorder.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

The FDA previously granted orphan-drug designation to EDG-5506 for the treatment of Duchenne and Becker muscular dystrophy, rare-pediatric-disease designation for the treatment of Duchenne, and fast-track designation for the treatment of Becker.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 13, 2024 08:49 ET (13:49 GMT)

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