{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-25-000100","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2025-10-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.150298+00:00","generated_at":"2026-05-17T03:34:29.454732+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Praxis ulixacaltamide Essential3 Phase 3 meets primary endpoint: 4.3 pt mADL11 improvement vs placebo (p<0.0001)","bullets":["Study 1: 4.3 pt mean improvement in mADL11 at Week 8 vs 1.7 pt placebo (p<0.0001); all key secondary endpoints significant.","Study 2 randomized withdrawal: 55% maintained response on ulixacaltamide vs 33% placebo (p=0.037, OR=2.7).","Common TEAEs included constipation, dizziness, euphoric mood, brain fog; no deaths or drug-related serious AEs.","Pre-NDA meeting submitted to FDA; NDA submission planned by early 2026.","Discontinuation rates due to TEAEs: 27% ulixacaltamide vs 1.7% placebo in Study 1."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-25-000100","json":"https://secwatch.observer/filing/0001689548-25-000100.json","markdown":"https://secwatch.observer/filing/0001689548-25-000100.md","text":"https://secwatch.observer/filing/0001689548-25-000100.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000100/0001689548-25-000100-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954825000100/prax-20251016.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:34:29.454732+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"}