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Axsome计划于2025年第三季度提交阿尔茨海默症激动症治疗药物AXS-05补充 ...
纽约 - 生物制药公司Axsome Therapeutics, Inc. (NASDAQ: AXSM)宣布计划于2025年第三季度向美国食品和药物管理局(FDA)提交AXS-05用于治疗阿尔茨海默症激动症的补充新药申请(sNDA)。这一决定是在公司收到与FDA进行的新药申请前会议的正式会议纪要后做出的,该纪要确认了Axsome的监管数据包足以支持sNDA的提交。
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