{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-25-000086","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2025-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.660395+00:00","generated_at":"2026-05-18T05:58:39.521063+00:00","sec_items":["7.01","8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA grants Breakthrough Therapy Designation for relutrigine in SCN2A/SCN8A DEEs","bullets":["FDA granted Breakthrough Therapy Designation for relutrigine in pediatric SCN2A and SCN8A DEEs.","BTD supported by positive data from EMBOLD study cohort 1 and 11-month open-label extension data.","Company initiated EMERALD study evaluating relutrigine across all DEEs.","Company entered quiet period ahead of RADIANT Phase 2 topline results expected by mid-2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-25-000086","json":"https://secwatch.observer/filing/0001689548-25-000086.json","markdown":"https://secwatch.observer/filing/0001689548-25-000086.md","text":"https://secwatch.observer/filing/0001689548-25-000086.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000086/0001689548-25-000086-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000086/prax-20250717.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T05:58:39.521063+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"}