By Katherine Hamilton
The Food and Drug Administration has accepted Capricor Therapeutics' application seeking approval of its cell therapy deramiocel for muscular dystrophy patients and granted it a priority review.
The FDA plans to take action on the application by Aug. 31, Capricor said Tuesday.
Shares rose 17% to $15.99 in pre-market trading Tuesday. They have nearly tripled in value over the past year.
Deramiocel is specifically being reviewed by the FDA to treat patients diagnosed with Duchenne muscular dystrophy cardiomyopathy.
If the San Diego company gets FDA marketing approval for deramiocel regarding the treatment of Duchenne muscular dystrophy by Sept. 30, 2026, it would be eligible to receive a priority review voucher based on its previous receipt of a rare pediatric disease designation.
The FDA grants priority review to medicine applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment of a serious condition.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
March 04, 2025 07:37 ET (12:37 GMT)
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