---
schema_version: "secwatch.filing_event.v1"
accession: "0001564590-22-023664"
form_type: "8-K"
ticker: "XENE"
cik: "0001582313"
company_name: "Xenon Pharmaceuticals Inc."
filed_at: "2022-06-21T23:59:59+00:00"
generated_at: "2026-06-25T00:24:18.513872+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Xenon announces positive FDA EOP2 meeting for XEN1101; Phase 3 to start H2 2022

## Summary
- FDA aligned on key Phase 3 elements; NDA submission planned after completion of X-TOLE2 trial plus existing Phase 2b data.
- XEN1101 Phase 3 program in focal onset seizures to begin second half 2022.
- Plans to initiate single Phase 3 trial (X-ACKT) for primary generalized tonic clonic seizures.
- Phase 2b X-TOLE met primary endpoint with p<0.001 across all doses; drug was well tolerated.
- Xenon expects differentiated profile based on Kv7 potassium channel mechanism and once-daily no-titration dosing.

## SEC filing metadata
- accession: 0001564590-22-023664
- form_type: 8-K
- ticker: XENE
- cik: 0001582313
- company_name: Xenon Pharmaceuticals Inc.
- filed_at: 2022-06-21T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1582313/000156459022023664/0001564590-22-023664-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1582313/000156459022023664/xene-8k_20220621.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001564590-22-023664
- JSON: https://secwatch.observer/filing/0001564590-22-023664.json
- Plain text: https://secwatch.observer/filing/0001564590-22-023664.txt

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