Edgewise Therapeutics receives FDA approval for muscular dystrophy drug trials, launches stock offering

BOULDER — Edgewise Therapeutics Inc. (Nasdaq: EWTX) has received authorization from the U.S. Food and Drug Administration to conduct Phase 2 clinical trials for EDG-5506, its flagship muscular dystrophy drug candidate, the company announced today in a news release.

EDG-5506 is an orally administered drug that is designed to treat disorders such as Duchenne Muscular Dystrophy and Becker Muscular Dystrophy, which cause progressive impairment of muscle function and lead patients to require the use of a wheelchair. Median life expectancy for patients is about 30 years. About 40,000 people worldwide are affected with Duchenne and Becker muscular dystrophy.

The Phase 2 trial will involve around 27 children ages 4 to 9 years with muscular dystrophy. It’s projected to begin the fourth quarter. Edgewise also is in the middle of conducting adult trials for EDG-5506.

Edgewise also launched a $100 million stock offering today that the company said would help fund its operations through 2025.

Edgewise stock opened today at $11.40 per share.

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