Registro de fuente primaria
MaterialSolicitud aceptada
Axsome: la FDA acepta la NDA para AXS-12 (reboxetine) en cataplexia; PDUFA 1 de mayo de 2027
La FDA aceptó la NDA para AXS-12 (reboxetine) para cataplexia en narcolepsia. La agencia estableció una fecha objetivo de acción PDUFA del 1 de mayo de 2027 e indicó que actualmente no planea celebrar una reunión del comité asesor.
Datos clave
- Presentado
- 15 jul 2026, 11:05
- Evento
- Solicitud aceptada
- Dirección
- Positivo
- 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 Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy FDA sets PDUFA target action date of May 1, 2027 NEW YORK, July 15, 2026 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee