Biohaven Ltd. has announced that the FDA is extending the PDUFA date for the new drug application (NDA) of troriluzole, aimed at treating spinocerebellar ataxia $(SCA)$, by three months to allow for a comprehensive review of recent submissions from the company. This decision pushes the expected announcement to the fourth quarter of 2025. Troriluzole, which has already been granted Fast-Track, Orphan Drug Designation, and Priority Review by the FDA, would be the first and only FDA-approved treatment for the rare, genetic, and life-threatening neurodegenerative disease if approved. The FDA has not raised any new concerns and is planning an advisory committee meeting to discuss the application, though the date has not been set.
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。