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Axsome: FDA, AXS-12(reboxetine) NDA 수리; PDUFA 2027년 5월 1일
FDA가 기면증 환자의 탈력발작 치료를 위한 AXS-12(reboxetine) NDA를 수리했습니다. FDA는 PDUFA 목표 조치일을 2027년 5월 1일로 설정했으며, 현재 자문위원회 회의를 개최할 계획이 없다고 밝혔습니다.
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EX-99.1 2 axsm-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy FDA sets PDUFA target action date of May 1, 2027 NEW YORK, July 15, 2026 (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 the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee