原始出處紀錄
決策級PDUFA 日期確定
AXS-05 治療阿茲海默症激動症的 sNDA 獲得優先審查，PDUFA 日期為 2026 年 4 月 30 日
FDA 已受理 AXS-05 用於治療阿茲海默症激動症的 sNDA，並授予優先審查資格，PDUFA 目標行動日期為 2026 年 4 月 30 日。AXS-05 已獲得此適應症的突破性療法認定。此申請受理確立了潛在批准的明確監管時間表。
關鍵事實
來源摘錄
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