Capricor Therapeutics (CAPR) said Thursday it has completed its biologics license application submission for deramiocel, which is intended to treat patients with Duchenne muscular dystrophy, or DMD, cardiomyopathy.
The company said it will receive a $10 million payment from its distribution partner, Nippon Shinyaku, as part of their US commercialization and distribution agreement.
Capricor has requested priority review, which could shorten the FDA review timeline from 10 months to six months after submission acceptance, the company said, adding that if deramiocel gains the FDA approval for DMD cardiomyopathy treatment, Capricor would also qualify for a priority review voucher due to its rare pediatric disease designation.
Shares of the company rose over 1% in recent Thursday trading.
Price: 14.00, Change: +0.19, Percent Change: +1.41
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