---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-211843"
form_type: "8-K"
ticker: "XENE"
cik: "0001582313"
company_name: "Xenon Pharmaceuticals Inc."
filed_at: "2026-05-07T23:59:59+00:00"
generated_at: "2026-05-14T21:41:59.834981+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Xenon reports positive Phase 3 X-TOLE2 data for azetukalner; NDA submission planned Q3 2026

## Summary
- Phase 3 X-TOLE2 met primary endpoint: median percent change in monthly FOS -53.2% (25mg) and -34.5% (15mg) vs -10.4% placebo (p<0.0001).
- NDA submission to FDA planned Q3 2026 based on X-TOLE2 and X-TOLE data.
- Cash and marketable securities $1.34B as of March 31; cash runway into 2029. Net loss $102.3M for Q1 2026.
- Enrollment ongoing for additional Phase 3 studies: X-TOLE3 (FOS), X-ACKT (PGTCS), X-NOVA2/3 (MDD), X-CEED (BPD); X-NOVA2 topline H1 2027.

## SEC filing metadata
- accession: 0001193125-26-211843
- form_type: 8-K
- ticker: XENE
- cik: 0001582313
- company_name: Xenon Pharmaceuticals Inc.
- filed_at: 2026-05-07T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1582313/000119312526211843/0001193125-26-211843-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1582313/000119312526211843/xene-20260507.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-211843
- JSON: https://secwatch.observer/filing/0001193125-26-211843.json
- Plain text: https://secwatch.observer/filing/0001193125-26-211843.txt

## Source-grounded claims
- claim_id: bd83c6be9645529b595798e3a7635c7a86d311a0
  claim: Xenon Pharmaceuticals Inc. reported financial results for the three months ended March 31, 2026.
  evidence_excerpt: On May 7, 2026, Xenon Pharmaceuticals Inc. (the “Company”) announced via press release the Company’s financial results for the three months ended March 31, 2026.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1582313/000119312526211843/0001193125-26-211843-index.htm

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