{"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","discovered_at":"2026-05-14T18:02:35.530448+00:00","generated_at":"2026-05-15T17:42:21.296046+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Xenon Phase 3 X-TOLE2 azetukalner meets primary endpoint; NDA submission Q3 2026","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-097577","json":"https://secwatch.observer/filing/0001193125-26-097577.json","markdown":"https://secwatch.observer/filing/0001193125-26-097577.md","text":"https://secwatch.observer/filing/0001193125-26-097577.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T17:42:21.296046+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}