{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-26-000069","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2026-06-29T20:40:34+00:00","discovered_at":"2026-06-29T20:42:00.631612+00:00","generated_at":"2026-06-29T20:42:18.742880+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA extends relutrigine PDUFA date by 3 months to Dec 27, 2026","bullets":["FDA extended relutrigine NDA review by 3 months due to additional sensitivity analyses submitted by Praxis.","New PDUFA target action date is December 27, 2026 (was September 27, 2026).","FDA deemed submission a major amendment; no new clinical studies, safety, or manufacturing concerns cited.","Company remains confident in application and continues preparations for launch."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-26-000069","json":"https://secwatch.observer/filing/0001689548-26-000069.json","markdown":"https://secwatch.observer/filing/0001689548-26-000069.md","text":"https://secwatch.observer/filing/0001689548-26-000069.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000069/0001689548-26-000069-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000069/prax-20260629.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-29T20:42:18.742880+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"}