美国食品药品监督管理局（FDA）已正式授予Axsome Therapeutics公司旗下在研药物AXS-05优先审评资格，并为该药物设定了处方药用户收费法案（PDUFA）目标行动日期为2026年4月30日。
这一重要监管进展意味着AXS-05的新药申请将进入加速审评通道。优先审评资格通常授予那些有望在治疗、诊断或预防疾病方面取得显著进展的潜在疗法。FDA此次设定的PDUFA日期，标志着监管机构将于2026年4月30日前完成对AXS-05申请的审查并做出最终决定。
此次监管里程碑为Axsome Therapeutics的核心产品管线注入了强劲动力。公司将继续与FDA保持密切沟通，积极推进AXS-05的审评进程。
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