Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
AXS-12 NDA tinanggap; PDUFA itinakda sa Mayo 1, 2027
Tinanggap ng FDA ang NDA para sa AXS-12 (reboxetine) para sa cataplexy sa narcolepsy at nagtalaga ng PDUFA target action date na Mayo 1, 2027. Ito ay nagtatatag ng susunod na regulatory milestone para sa asset.
Mahahalagang fact
- Na-file
- Ago 10, 2026, 11:05 AM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
AXSMAxsome- Asset
- reboxetine
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · May 1, 2027
Sipi mula sa source
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
Higit pa tungkol sa asset na ito
Materyal
Hul 15, 2026
11:05 AM
AXSMAxsome