secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2026-07-15T11:05:15+00:00
Accession:  0001193125-26-304039
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Axsome's NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy; PDUFA May 1, 2027
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- FDA accepted for filing Axsome's New Drug Application for AXS-12 (reboxetine) to treat cataplexy in narcolepsy.
- PDUFA target action date set for May 1, 2027.
- FDA indicated it does not currently plan to hold an advisory committee meeting for the application.
- Axsome Therapeutics (AXSM) announced the acceptance on July 15, 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/0001193125-26-304039-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000119312526304039/axsm-20260715.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-304039

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