智通财经APP获悉,周一,疫苗巨头Moderna(MRNA.US)、基因疗法公司Sarepta Therapeutics(SRPT.US)跌近9%,分别报28.34美元及64.09美元。消息面上,美国食品和药物管理局(FDA)官员Dr. Peter Marks宣布辞职,他领导着FDA生物制品评估和研究中心(CBER),是FDA内部最知名的职业官员之一。作为生物技术行业的重要监管者,Marks对基因疗法和疫苗的审批具有关键影响力,他长期以来支持加快罕见病药物的审批进程,帮助许多生物科技公司推动创新疗法上市。此外,Marks在新冠疫苗研发方面也发挥了重要作用。
由于Marks的离任可能影响FDA未来对创新药物的监管态度,生物科技投资者情绪急剧恶化,导致相关股票大幅下跌。市场普遍担忧,FDA在生物制品审批方面的政策可能会趋于保守,从而影响未来基因疗法和疫苗的推进速度。
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