secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2024-09-04T23:59:59+00:00
Accession:  0000950170-24-103098
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Axsome's NDA resubmission for AXS-07 migraine treatment; PDUFA date Jan 31, 2025
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- FDA acknowledged Class 2 resubmission of NDA for AXS-07 for acute migraine treatment.
- PDUFA goal date set for January 31, 2025.
- AXS-07 is a novel oral drug candidate for acute migraine.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024103098/0000950170-24-103098-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024103098/axsm-20240904.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-103098

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