Capricor Therapeutics (CAPR) shares were down more than 11% in recent trading on Monday after the company said the US Food and Drug Administration plans to hold an advisory committee meeting to review its biologics license application for deramiocel, an investigational cell therapy for treating cardiomyopathy in Duchenne muscular dystrophy patients.
Capricor said no significant deficiencies were identified in the application during a recent mid-cycle review meeting with the FDA. The agency is expected to decide by the Aug. 31 Prescription Drug User Fee Act target action date.
An official date for the advisory committee meeting has not yet been set, according to Capricor.
Price: 10.54, Change: -1.32, Percent Change: -11.13
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。