原始来源记录
重大PDUFA 日期确定
AXS-12 NDA获受理；PDUFA日期定为2027年5月1日
FDA受理了AXS-12（瑞波西汀）用于发作性睡病猝倒症的NDA申请，并指定PDUFA目标行动日期为2027年5月1日。这确立了该资产的下一个监管里程碑。
关键事实
- 申报时间
- 2026年8月10日 11:05
- 事件
- PDUFA 日期确定
- 方向
- 中性
- 来源
- SEC 8-K
- 可信度
- 有来源
- 日历
- FDA 审批决定 (PDUFA) · 2027年5月1日
来源摘录
EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update Total 2Q 2026 net product revenue of $218.4 million, representing 46% year-over-year growth AUVELITY ® 2Q 2026 net product sales of $180.3 million, representing 51% year-over-year growth SUNOSI ® 2Q 2026 net product revenue of $35.8 million, representing 20% year-over-year growth SYMBRAVO ® 2Q 2026 net product sales of $2.3 million AUVELITY launched for treatment of agitation associated with dementia due to Alzheimer’s disease in June 2026 NDA submission for AXS-12 for cataplexy in narcolepsy accepted by the FDA with PDUFA target action date of May 1, 2027 FOCUS-2 and FOCUS-3 Phase 3 trials of solriamfetol in children and adolescents with