原始来源记录
决策级PDUFA 日期确定
AXS-05 阿尔茨海默症激越适应症 sNDA 获优先审评，PDUFA 日期为 2026 年 4 月 30 日
FDA 已受理 AXS-05 治疗阿尔茨海默症激越的 sNDA 并授予优先审评，PDUFA 目标行动日期为 2026 年 4 月 30 日。AXS-05 已获得该适应症的突破性疗法认定。受理决定为潜在获批确立了明确的监管时间表。
关键事实
来源摘录
EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Total 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing 65% and 66% year-over-year growth AUVELITY ® 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively, representing 68% and 74% year-over-year growth SUNOSI ® 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively, representing 40% and 32% year-over-year growth SYMBRAVO ® 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively sNDA for AXS-05 for the treatment of Alzheimer’s disease agitation granted Priority Revie