---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-097577"
form_type: "8-K"
ticker: "XENE"
cik: "0001582313"
company_name: "Xenon Pharmaceuticals Inc."
filed_at: "2026-03-09T23:59:59+00:00"
generated_at: "2026-05-15T17:42:21.296046+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Xenon Phase 3 X-TOLE2 azetukalner meets primary endpoint; NDA submission Q3 2026

## Summary
- Primary endpoint MPC: 25mg -53.2% vs placebo -10.4% (p<0.000000000006); placebo-adjusted -42.7%, outperforming Phase 2b.
- Key secondary RR50: 54.8% (25mg) vs 20.8% placebo (p=0.00000008).
- Safety consistent: most common TEAEs dizziness (20.5%), headache (8.8%), somnolence (8.8%), fatigue (7.6%).
- NDA submission to FDA planned Q3 2026 for focal onset seizures.
- Data to be presented as Late Breaking Science at AAN Annual Meeting in April 2026.

## SEC filing metadata
- accession: 0001193125-26-097577
- form_type: 8-K
- ticker: XENE
- cik: 0001582313
- company_name: Xenon Pharmaceuticals Inc.
- filed_at: 2026-03-09T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1582313/000119312526097577/0001193125-26-097577-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1582313/000119312526097577/d107087d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-097577
- JSON: https://secwatch.observer/filing/0001193125-26-097577.json
- Plain text: https://secwatch.observer/filing/0001193125-26-097577.txt

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