{"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","discovered_at":"2026-05-14T18:04:01.311585+00:00","generated_at":"2026-06-25T00:24:18.513872+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Xenon announces positive FDA EOP2 meeting for XEN1101; Phase 3 to start H2 2022","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001564590-22-023664","json":"https://secwatch.observer/filing/0001564590-22-023664.json","markdown":"https://secwatch.observer/filing/0001564590-22-023664.md","text":"https://secwatch.observer/filing/0001564590-22-023664.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T00:24:18.513872+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"}