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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, Dec. 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 pot Dec 31, 2025 - $AXSM
Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 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 the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment Dec 31, 2025 - $AXSM
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