生物制药公司Sarepta Therapeutics (SRPT)周五盘中股价暴跌37.10%,创下9年多来的新低,这一大跌主要由于公司基因疗法研究中又一名患者死亡的消息引发的投资者担忧。
据报道,一名51岁男性患者在参与Sarepta公司SRP-9004基因疗法早期研究时因急性肝功能衰竭死亡。SRP-9004是一种针对肢腰肌营养不良症(LGMD)的实验性治疗。这是今年Sarepta公司报告的第三起与基因疗法相关的患者死亡事件,此前已有两名接受Elevidys治疗的杜氏肌营养不良症患者死亡。
更令投资者担忧的是,有消息称美国食品和药物管理局(FDA)可能要求Sarepta停止其获批基因疗法Elevidys的所有发货。FDA已经在调查先前两起死亡病例,并在Elevidys的标签上增加了严重警告。这些事件可能会严重影响Sarepta的核心业务,尤其是Elevidys是FDA批准的唯一一种用于治疗杜氏肌营养不良症的基因疗法。分析人士指出,这些安全性问题可能会导致公司其他在研基因疗法面临更严格的审查,从而影响其商业前景。
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