secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2025-12-31T23:59:59+00:00
Accession:  0001193125-25-337644
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA grants Priority Review to AXS-05 for Alzheimer's agitation; pre-NDA meeting supports AXS-12 narcolepsy filing
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- FDA accepted sNDA for AXS-05 (dextromethorphan/bupropion) for Alzheimer's agitation; Priority Review with PDUFA date April 30, 2026.
- Pre-NDA meeting minutes confirm data package sufficient for AXS-12 (reboxetine) in narcolepsy cataplexy; NDA submission expected January 2026.
- AXS-12 has Orphan Drug Designation for narcolepsy, potentially providing 7 years US exclusivity if approved.
- AXS-05 previously received Breakthrough Therapy designation for Alzheimer's agitation (June 2020).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000119312525337644/0001193125-25-337644-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000119312525337644/axsm-20251231.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-337644

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer