---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-130755"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2024-11-26T23:59:59+00:00"
generated_at: "2026-05-29T17:51:00.737548+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Axsome's AXS-12 meets primary endpoint in ENCORE Phase 3 trial for narcolepsy with cataplexy

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-24-130755
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2024-11-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000095017024130755/0000950170-24-130755-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000095017024130755/axsm-20241126.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-130755
- JSON: https://secwatch.observer/filing/0000950170-24-130755.json
- Plain text: https://secwatch.observer/filing/0000950170-24-130755.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.