{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-25-000114","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2025-12-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.150918+00:00","generated_at":"2026-05-16T13:59:11.200031+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Praxis gains FDA alignment for ulixacaltamide NDA; relutrigine & vormatrigine trials positive","bullets":["Ulixacaltamide pre-NDA meeting with FDA completed; NDA submission expected early 2026.","Relutrigine EMBOLD study stopped early for efficacy; 53% placebo-adjusted seizure reduction (p<0.0002) over 16 weeks.","Relutrigine: 66% increase in motor seizure-free days (p=0.034); no drug-related serious adverse events.","Vormatrigine RADIANT FOS cohort (n=62): 54% median seizure reduction at 8 weeks; 11% seizure-free for entire 8-week period.","Vormatrigine POWER1 pivotal study fully enrolled; POWER2 on track for H2 2026; POWER3 monotherapy starts H1 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-25-000114","json":"https://secwatch.observer/filing/0001689548-25-000114.json","markdown":"https://secwatch.observer/filing/0001689548-25-000114.md","text":"https://secwatch.observer/filing/0001689548-25-000114.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000114/0001689548-25-000114-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000114/prax-20251204.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:59:11.200031+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"}