Moderna, Inc. (MRNA) 今日盘中股价大幅下挫，跌幅达12.16%，引起了市场的广泛关注。
消息面上，此次股价大跌主要源于监管方面的重大利空。美国食品药品监督管理局（FDA）已通知Moderna，拒绝启动对其研究性季节性流感疫苗mRNA-1010生物制品许可申请的审查。FDA在发出的不予立卷通知中指出，拒绝审查的唯一原因是该公司在三期临床试验中选择已获批的标准剂量季节性流感疫苗作为对照，认为其缺乏一项“充分且严格对照”的研究，且对照组未能体现“现有最佳医疗标准”。
Moderna公司对此回应称，FDA的这一决定并未指出其产品存在任何具体的安全性有效性问题，并认为该决定与监管机构此前在试验方案沟通阶段的书面反馈意见不一致。公司已要求与FDA会面以明确后续方向。这一监管挫折直接打击了市场对其流感疫苗在美国获批前景的信心，从而引发了股价的剧烈波动。
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.