Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer's Disease Agitation Supporting NDA Submission [Yahoo! Finance]
Axsome Therapeutics, Inc. (AXSM)
Last axsome therapeutics, inc. earnings: 3/12 07:00 am
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Source: Yahoo! Finance
NEW YORK, March 03, 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 a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer's disease agitation. AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor. The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company's planned sNDA submission including the clinical and nonclinical requirements. Based on the feedback from the FDA, the Company's regulatory data package would be sufficient for the submission of an sNDA for AXS-05 for the treatment of Alzheimer's disease agitation. Axsome anticipates submitting the planned sN
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News
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AXSM
Earnings
- 11/3/25 - Miss
AXSM
Sec Filings
- 12/4/25 - Form 4
- 12/4/25 - Form 144
- 12/3/25 - Form 144
- AXSM's page on the SEC website