Axsome: FDA menyetujui AUVELITY untuk agitasi Alzheimer

FDA menyetujui AUVELITY untuk agitasi yang terkait dengan demensia akibat penyakit Alzheimer, memperluas labelnya dari MDD ke indikasi kedua. Perusahaan menyatakan peluncuran komersial akan berjalan sesuai rencana pada Juni 2026. Persetujuan ini menambahkan indikasi baru yang pertama di kelasnya pada produk yang dipasarkan.

Fakta utama

Diajukan: 4 Mei 2026, 11.07
Peristiwa: Persetujuan FDA
Arah: Positif
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 First Quarter 2026 Financial Results and Provides Business Update Total 1Q 2026 net product revenue of $191.2 million, representing 57% year-over-year growth AUVELITY ® 1Q 2026 net product sales of $153.2 million, representing 59% year-over-year growth SUNOSI ® 1Q 2026 net product revenue of $33.9 million, representing 34% year-over-year growth SYMBRAVO ® 1Q 2026 net product sales of $4.1 million AUVELITY approved for the treatment of agitation associated with dementia due to Alzheimer’s disease NDA for AXS-12 for the treatment of cataplexy in narcolepsy submitted to the FDA AXS-20 (balipodect), potentially first-in-class, pre-Phase 3, PDE10A inhibitor for schizophrenia and Tourette syndrome, added to pip

SEC 8-K