{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-076478","form_type":"8-K","ticker":"STOK","cik":"0001623526","company_name":"Stoke Therapeutics, Inc.","filed_at":"2024-03-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.845504+00:00","generated_at":"2026-06-04T08:29:47.585254+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Stoke reports STK-001 data: 85% median seizure reduction at 3 months; FDA allows 70mg dosing","bullets":["Phase 1/2a: 70mg (2-3 doses) showed median 85% reduction in convulsive seizure frequency at 3 months (n=10) and 74% at 6 months (n=9) after last dose.","OLE studies: durable seizure reductions and clinically meaningful improvements in cognition/behavior (VINELAND-3) over 12 months with continued 30mg or 45mg dosing.","FDA clearance for three 70mg doses followed by 45mg; company plans to meet with regulators to discuss registrational study design.","STK-001 generally well-tolerated; 30% (24/81) had treatment-related TEAEs, most commonly CSF protein elevation and procedural vomiting.","92% of eligible patients enrolled in OLEs with 84% remaining; data contrast with natural history showing no improvement in seizures or cognition."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-076478","json":"https://secwatch.observer/filing/0001193125-24-076478.json","markdown":"https://secwatch.observer/filing/0001193125-24-076478.md","text":"https://secwatch.observer/filing/0001193125-24-076478.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1623526/000119312524076478/0001193125-24-076478-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1623526/000119312524076478/d816172d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T08:29:47.585254+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"}