Axsome mengajukan sNDA untuk AXS-05 pada agitasi penyakit Alzheimer

Axsome telah mengajukan NDA tambahan ke FDA untuk AXS-05 pada agitasi penyakit Alzheimer. Perusahaan berencana mengumumkan keputusan FDA mengenai penerimaan pengajuan tersebut. AXS-05 memiliki penetapan Breakthrough Therapy untuk indikasi ini.

Fakta utama

Diajukan: 3 Nov 2025, 12.06
Peristiwa: Permohonan diajukan
Arah: Netral
Perusahaan: AXSMAxsome
Aset: AXS-05
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update Total 3Q 2025 net product revenue of $171.0 million, representing 63% year-over-year growth AUVELITY ® 3Q 2025 net product sales of $136.1 million, representing 69% year-over-year growth SUNOSI ® 3Q 2025 net product revenue of $32.8 million, representing 35% year-over-year growth SYMBRAVO ® 3Q 2025 net product sales of $2.1 million sNDA for AXS-05 in Alzheimer’s disease agitation submitted to the FDA Company to host conference call today at 8:00 AM Eastern NEW YORK, November 3, 2025 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) diso

SEC 8-K