{"schema_version":"secwatch.filing_event.v1","accession":"0001515673-26-000006","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2026-09-17T19:55:37+00:00","discovered_at":"2026-09-17T19:57:18.615379+00:00","generated_at":"2026-09-17T19:57:24.087996+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Ultragenyx gets FDA standard full approval for FAYUVI, first Sanfilippo type A treatment","bullets":["FDA granted standard full approval of FAYUVI (UX111) for pediatric MPS IIIA (Sanfilippo syndrome type A) on Sept 17, 2026.","FAYUVI is the first-ever FDA-approved treatment for Sanfilippo syndrome type A, a progressive fatal neurodegenerative disease.","This is Ultragenyx's second gene therapy approval; company received a Priority Review Voucher upon approval.","Approval covers pediatric patients with mucopolysaccharidosis type IIIA; trade name rebisufligene etisparvovec-hopf."],"urls":{"canonical":"https://secwatch.observer/filing/0001515673-26-000006","json":"https://secwatch.observer/filing/0001515673-26-000006.json","markdown":"https://secwatch.observer/filing/0001515673-26-000006.md","text":"https://secwatch.observer/filing/0001515673-26-000006.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000151567326000006/0001515673-26-000006-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000151567326000006/rare-20260917.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-17T19:57:24.087996+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"}