原始出處紀錄
重大PDUFA 日期確定
AXS-05治療阿茲海默症躁動的sNDA獲受理,PDUFA日期為2026年4月30日
FDA accepted the supplemental NDA for AXS-05 in Alzheimer’s agitation and granted Priority Review, setting a PDUFA target action date of April 30, 2026. The filing is supported by four Phase 3 trials and a long-term safety study. Priority Review shortens the FDA review clock to six months.
關鍵事實
來源摘錄
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