アルツハイマー病興奮症状に対するAXS-05のsNDAが受理され、PDUFAは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.

主要事実

提出: 2025年12月31日 12:10
イベント: PDUFA 日設定
方向: 中立
企業: AXSMアクソーム
アセット: AXS-05
出典: SEC 8-K
信頼度: 出典あり
カレンダー: FDA 審査決定 (PDUFA) · 2026年4月30日 · 承認

出典の抜粋

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

SEC 8-K