原始来源记录
重大PDUFA 日期确定
AXS-05 阿尔茨海默症激越 sNDA 获受理，PDUFA 日期定于 2026 年 4 月 30 日
FDA 已受理 AXS-05 用于阿尔茨海默症激越的补充 NDA 并授予优先审评，PDUFA 目标行动日期定于 2026 年 4 月 30 日。该申报由四项 3 期试验和一项长期安全性研究支持。优先审评将 FDA 审评周期缩短至六个月。
关键事实
来源摘录
EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission New Drug Application (NDA) submission on track for January 2026 NEW YORK, December 31, 2025 (Globe Newswire) – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting an NDA submission for AXS-12 in narcolepsy. AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. The purpose of the meeting was to reach agreement with the