{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-25-000116","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2025-12-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.151073+00:00","generated_at":"2026-05-16T13:31:08.531052+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Praxis gets FDA nod to simplify EMBRAVE3 study; relutrigine NDA on track for early 2026","bullets":["FDA agreed to convert EMBRAVE3 from double-blind to single-arm baseline-controlled study, enrolling 30 patients (down from 40).","Primary analysis will be change from baseline in countable motor seizures; all screening patients now assigned to elsunersen.","EMBRAVE Part A (9 patients, 3:1 randomization) topline results expected in first half of 2026.","FDA confirmed that Praxis can file a New Drug Application for relutrigine in SCN2A and SCN8A DEEs in early 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-25-000116","json":"https://secwatch.observer/filing/0001689548-25-000116.json","markdown":"https://secwatch.observer/filing/0001689548-25-000116.md","text":"https://secwatch.observer/filing/0001689548-25-000116.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000116/0001689548-25-000116-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000116/prax-20251209.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:31:08.531052+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"}