{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-272559","form_type":"8-K","ticker":"STOK","cik":"0001623526","company_name":"Stoke Therapeutics, Inc.","filed_at":"2024-12-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.020465+00:00","generated_at":"2026-05-29T06:35:39.427395+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Stoke Therapeutics receives FDA Breakthrough Therapy Designation for zorevunersen in Dravet syndrome","bullets":["FDA granted Breakthrough Therapy Designation for zorevunersen to treat Dravet syndrome with a confirmed SCN1A mutation.","Phase 1/2a data showed 85% median reduction in convulsive seizure frequency at 3 months post-last dose of 70mg.","OLE study patients on 45mg maintenance achieved 87% median reduction in seizures at month eight.","Patients showed continuous improvements in cognition and behavior through 2 years of treatment per Vineland-3.","Company plans to provide Phase 3 registrational study update by end of 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-272559","json":"https://secwatch.observer/filing/0001193125-24-272559.json","markdown":"https://secwatch.observer/filing/0001193125-24-272559.md","text":"https://secwatch.observer/filing/0001193125-24-272559.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1623526/000119312524272559/0001193125-24-272559-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1623526/000119312524272559/d916273d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-29T06:35:39.427395+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"}