Drugs.com New Drug ApplicationsOriginal article
Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy
NDA FilingAXS-12Positive
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Summary
Axsome Therapeutics announced FDA acceptance of its New Drug Application for AXS-12 for the treatment of cataplexy in narcolepsy. The acceptance enables regulatory review and potential path toward approval.
Outcome Details
FDA acceptance of New Drug Application
Importance:7/10
Sentiment:
0.70
FDANDA acceptanceCNS disordersnarcolepsycataplexy
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Published by Drugs.com New Drug Applications on July 15, 2026 2:07 AM