{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-002550","form_type":"8-K","ticker":"STOK","cik":"0001623526","company_name":"Stoke Therapeutics, Inc.","filed_at":"2025-01-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.222063+00:00","generated_at":"2026-05-28T08:31:05.572053+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Stoke announces global regulatory alignment for Phase 3 study of zorevunersen in Dravet syndrome","bullets":["Aligned with FDA, EMA, and PMDA for Phase 3 EMPEROR; study to start mid-2025, data by end of 2027.","Primary endpoint: reduction in major motor seizure frequency; key secondary: cognition and behavior via Vineland-3.","Dosing: two 70mg loading doses then two 45mg maintenance doses over 52 weeks; ages 2 to <18.","Commercial opportunity: >38,000 patients with Dravet syndrome in seven major markets.","FDA Breakthrough Therapy designation; prior OLE data: 87% median seizure reduction at month 8."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-002550","json":"https://secwatch.observer/filing/0001193125-25-002550.json","markdown":"https://secwatch.observer/filing/0001193125-25-002550.md","text":"https://secwatch.observer/filing/0001193125-25-002550.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1623526/000119312525002550/0001193125-25-002550-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1623526/000119312525002550/d915192d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T08:31:05.572053+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"}