一次情報の記録
重要申請提出
Axsome、アルツハイマー病の興奮症状に対するAXS-05のsNDAを提出
Axsomeは、アルツハイマー病の興奮症状に対するAXS-05の補足的NDAをFDAに提出した。同社はFDAによる申請受理の決定を発表する予定である。AXS-05は本適応でBreakthrough Therapy designationを取得している。
主要事実
出典の抜粋
EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update Total 3Q 2025 net product revenue of $171.0 million, representing 63% year-over-year growth AUVELITY ® 3Q 2025 net product sales of $136.1 million, representing 69% year-over-year growth SUNOSI ® 3Q 2025 net product revenue of $32.8 million, representing 35% year-over-year growth SYMBRAVO ® 3Q 2025 net product sales of $2.1 million sNDA for AXS-05 in Alzheimer’s disease agitation submitted to the FDA Company to host conference call today at 8:00 AM Eastern NEW YORK, November 3, 2025 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) diso