sNDA AXS-05 untuk agitasi Alzheimer diberikan Tinjauan Prioritas, PDUFA 30 April 2026

FDA menerima sNDA untuk AXS-05 pada agitasi penyakit Alzheimer dan memberikan Tinjauan Prioritas dengan tanggal tindakan target PDUFA 30 April 2026. AXS-05 telah memiliki penetapan Terapi Terobosan untuk indikasi ini. Penerimaan pengajuan menetapkan garis waktu regulasi yang tegas untuk potensi persetujuan.

Fakta utama

Diajukan: 23 Feb 2026, 12.18
Peristiwa: Tanggal PDUFA ditetapkan
Arah: Netral
Perusahaan: AXSMAxsome
Aset: AXS-05
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 30 Apr 2026 · Disetujui

Kutipan sumber

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