Registro de fuente primaria
MaterialFecha PDUFA fijada
Aceptada la NDA de AXS-12; PDUFA fijada para el 1 de mayo de 2027
La FDA aceptó la NDA de AXS-12 (reboxetina) para la cataplexia en narcolepsia y asignó una fecha objetivo de acción PDUFA del 1 de mayo de 2027. Esto establece el próximo hito regulatorio para el activo.
Datos clave
- Presentado
- 10 ago 2026, 11:05
- Evento
- Fecha PDUFA fijada
- Dirección
- Neutral
- Empresa
AXSMAxsome- Activo
- reboxetine
- Fuente
- SEC 8-K
- Confianza
- Con fuente
- Calendario
- Decisión de la FDA (PDUFA) · 1 may 2027
Extracto de la fuente
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