알츠하이머 초조 증상 치료제 AXS-05 sNDA 접수, PDUFA 2026년 4월 30일

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.

핵심 사실

제출: 2025년 12월 31일 PM 12:10
이벤트: PDUFA 날짜 확정
방향: 중립
기업: AXSM악솜
자산: AXS-05
출처: SEC 8-K
신뢰도: 출처 확인
캘린더: FDA 심사 결정 (PDUFA) · 2026년 4월 30일 · 승인

출처 발췌

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