Capricor Therapeutics' (CAPR) biologics license application for deramiocel to treat Duchenne muscular dystrophy cardiomyopathy was accepted and granted priority review by the US Food and Drug Administration, a Nippon Shinyaku subsidiary said Monday.
Nippon Shinyaku and Capricor entered into an exclusive distribution agreement for deramiocel for the US in January 2022, with Nippon unit NS Pharma responsible for commercialization and distribution, the company said.
The FDA has set a target action date of Aug. 31 for the biologics license application, NS Pharma said
Shares of Capricor Therapeutics were down 5.8% in recent trading.
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