Axsome submete sNDA para AXS-05 na agitação da doença de Alzheimer

Axsome submeteu uma NDA suplementar à FDA para AXS-05 na agitação da doença de Alzheimer. A empresa planeja anunciar a decisão da FDA sobre a aceitação do pedido. AXS-05 possui designação de Terapia Inovadora para esta indicação.

Fatos principais

Arquivado: 3 de nov. de 2025, 12:06
Evento: Pedido submetido
Direção: Neutro
Empresa: AXSMAxsome
Ativo: AXS-05
Fonte: SEC 8-K
Confiança: Com fonte

Trecho da fonte

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

SEC 8-K