secwatch.observer — SEC 8-K summary
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Issuer:     Axsome Therapeutics, Inc. (AXSM)
CIK:        0001579428
Form:       8-K
Filed at:   2024-11-26T23:59:59+00:00
Accession:  0000950170-24-130755
Event type: other_material
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Axsome's AXS-12 meets primary endpoint in ENCORE Phase 3 trial for narcolepsy with cataplexy
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- Primary endpoint met: AXS-12 significantly reduced cataplexy attacks vs placebo (p=0.017); placebo worsening +10.29 attacks/week vs +1.32 with AXS-12.
- Improvements in cognition and overall narcolepsy: NSAQ ability to concentrate (p=0.011) and PGI-C global improvement (p=0.024) both significant.
- During open-label, 72% achieved ≥50% cataplexy reduction at 1 month, 82% at 6 months; mean ESS reduced 5.6 points at 1 month, 7.3 at 6 months.
- Company plans to expedite NDA filing and request pre-NDA meeting with FDA; Orphan Drug Designation grants 7-year exclusivity upon approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024130755/0000950170-24-130755-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1579428/000095017024130755/axsm-20241126.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-130755

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