1차 출처 기록
중대신청 제출
Axsome, 알츠하이머병 초조증에 대한 AXS-05의 sNDA 제출
Axsome는 알츠하이머병 초조증에 대한 AXS-05의 보충 NDA를 FDA에 제출했습니다. 회사는 제출물 수리 여부에 대한 FDA의 결정을 발표할 예정입니다. AXS-05는 해당 적응증에 대해 Breakthrough Therapy 지정을 받았습니다.
핵심 사실
출처 발췌
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