{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-139084","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2026-04-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.400284+00:00","generated_at":"2026-05-15T07:49:58.807889+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA accepts resubmitted BLA for UX111 gene therapy; PDUFA date Sept 19, 2026","bullets":["FDA accepted for review resubmitted BLA for UX111 (rebisufligene etisparvovec) AAV9 gene therapy.","UX111 is intended for Sanfilippo syndrome Type A (MPS IIIA) under accelerated approval pathway.","PDUFA action date set for September 19, 2026.","No new safety or efficacy data disclosed; review outcome remains uncertain."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-139084","json":"https://secwatch.observer/filing/0001193125-26-139084.json","markdown":"https://secwatch.observer/filing/0001193125-26-139084.md","text":"https://secwatch.observer/filing/0001193125-26-139084.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526139084/0001193125-26-139084-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526139084/rare-20260402.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T07:49:58.807889+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"}