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AI brief of an SEC Form 8-K · Axsome Therapeutics, Inc. (AXSM)

Axsome FDA accepts AXS-12 narcolepsy NDA; PDUFA target date set for May 1, 2027

Neutral Impact 3 of 5 legal/regulatory Written later

Axsome Therapeutics said the FDA accepted its New Drug Application for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA set a PDUFA target action date of May 1, 2027, and does not currently plan an advisory committee meeting. AXS-12 is not approved by the FDA, and the filing contains no financial results.

Key points

  • FDA accepted the New Drug Application for AXS-12 (reboxetine) for cataplexy in narcolepsy for filing
  • PDUFA target action date set for May 1, 2027
  • FDA does not currently plan to hold an advisory committee meeting
  • AXS-12 has FDA Orphan Drug Designation for the treatment of narcolepsy

The filing

CompanyAxsome Therapeutics, Inc. (AXSM)
Form8-K, current report
Filed with the SECJul 15, 2026, 7:05 AM ET
Accession number0001193125-26-304039

Items reported: 8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:38 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on July 15, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.