Catatan sumber primer
MaterialTanggal PDUFA ditetapkan
AXS-12 NDA diterima; PDUFA ditetapkan pada 1 Mei 2027
FDA menerima NDA untuk AXS-12 (reboxetine) untuk katapleksi pada narkolepsi dan menetapkan tanggal aksi target PDUFA pada 1 Mei 2027. Hal ini menetapkan tonggak regulasi berikutnya untuk aset tersebut.
Fakta utama
- Diajukan
- 10 Agu 2026, 11.05
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
AXSMAxsome- Aset
- reboxetine
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- Kalender
- Keputusan FDA (PDUFA) · 1 Mei 2027
Kutipan sumber
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
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Material
15 Jul 2026
11.05
AXSMAxsome