AXS-05 sNDA para sa Alzheimer’s agitation binigyan ng Priority Review, PDUFA Abril 30, 2026

Tinanggap ng FDA ang sNDA para sa AXS-05 sa Alzheimer’s disease agitation at binigyan ng Priority Review na may PDUFA target action date na Abril 30, 2026. Mayroon nang Breakthrough Therapy designation ang AXS-05 para sa indikasyong ito. Ang pagtanggap ng filing ay nagtatakda ng malinaw na regulatory timeline para sa posibleng pag-apruba.

Mahahalagang fact

Na-file: Peb 23, 2026, 12:18 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: AXSMAxsome
Asset: AXS-05
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Abr 30, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Total 4Q and full year 2025 net product revenue of $196.0 million and $638.5 million, respectively, representing 65% and 66% year-over-year growth AUVELITY ® 4Q and full year 2025 net product sales of $155.1 million and $507.1 million, respectively, representing 68% and 74% year-over-year growth SUNOSI ® 4Q and full year 2025 net product revenue of $36.7 million and $124.8 million, respectively, representing 40% and 32% year-over-year growth SYMBRAVO ® 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively sNDA for AXS-05 for the treatment of Alzheimer’s disease agitation granted Priority Revie

SEC 8-K