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.
Price: 12.09, Change: -0.73, Percent Change: -5.66
免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。