Muscular Dystrophy drug maker on FDA fast track

BOULDER — Edgewise Therapeutics Inc. (NASDAQ: EWTX) said a drug it’s developing was given fast track status by the U.S. Food and Drug Administration.

The potential treatment is aimed at two types of muscular dystrophy, Duchenne and Becker, to “arrest muscle fiber breakdown [and] protect injury-susceptible fast skeletal muscle fibers,” a press release said.

Shares in the clinical-stage pharmaceutical company rose about 10% in early trading to a market cap of $801 million.

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The drug — called EDG-5506 for purposes of the Phase I trial — is set for expedited review available to “new therapeutics [for] serious conditions and [to] fill an unmet medical need.”

Edgewise said in the release it expects to have more Phase I data this year.

BizWest reported on the drug’s progress earlier.

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