生物制药公司Biohaven Pharmaceutical Holding Co Ltd.(股票代码:BHVN)今日盘中股价大跌14.5%,引发市场广泛关注。此次暴跌主要源于美国食品和药物管理局(FDA)延长了该公司关键遗传病药物的审查期。
据报道,FDA将Biohaven的遗传病药物曲利卢唑(troriluzole)上市申请的审查期限延长了三个月。Biohaven表示,FDA目前预计将在今年第四季度做出决定。虽然FDA未提出新的安全问题,但计划召开咨询委员会会议讨论该申请,具体日期尚未确定。这一消息无疑对投资者信心造成了重大打击,导致股价大幅下挫。
值得注意的是,曲利卢唑是Biohaven的重要在研产品之一,其审批进程对公司未来发展具有重要意义。FDA审查期的延长可能会推迟该药物的上市时间,从而影响公司的收入预期和市场竞争力。这也解释了为什么市场对这一消息反应如此强烈。此外,这一事件也引发了市场对FDA审查能力的担忧,尤其是在特朗普政府大规模裁员后,FDA的新药审批效率可能受到影响。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.