{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-062568","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2026-02-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.289697+00:00","generated_at":"2026-05-16T01:08:18.361665+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA accepts Ultragenyx's BLA for DTX401 gene therapy for GSDIa with Priority Review, PDUFA Aug 23, 2026","bullets":["FDA accepted Biologics License Application for DTX401 (pariglasgene brecaparvovec) to treat Glycogen Storage Disease Type Ia.","Granted Priority Review; Prescription Drug User Fee Act (PDUFA) action date is August 23, 2026.","DTX401 is an AAV-based gene therapy targeting a rare metabolic disorder with no approved therapies.","BLA acceptance triggers regulatory milestone; company may be eligible for priority review voucher if approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-062568","json":"https://secwatch.observer/filing/0001193125-26-062568.json","markdown":"https://secwatch.observer/filing/0001193125-26-062568.md","text":"https://secwatch.observer/filing/0001193125-26-062568.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526062568/0001193125-26-062568-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526062568/rare-20260223.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T01:08:18.361665+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"}