{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-26-000033","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2026-04-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.738123+00:00","generated_at":"2026-05-15T06:23:59.979932+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Praxis Precision: FDA accepts NDA for ulixacaltamide in essential tremor; PDUFA Jan 29, 2027","bullets":["FDA accepted NDA for ulixacaltamide HCl to treat essential tremor in adults; PDUFA target action date January 29, 2027.","No advisory committee meeting will be held for the ulixacaltamide NDA review.","The NDA seeks approval for a novel small-molecule therapy for a common movement disorder."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-26-000033","json":"https://secwatch.observer/filing/0001689548-26-000033.json","markdown":"https://secwatch.observer/filing/0001689548-26-000033.md","text":"https://secwatch.observer/filing/0001689548-26-000033.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000033/0001689548-26-000033-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000033/prax-20260414.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T06:23:59.979932+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"}