{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-030590","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2026-01-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.288960+00:00","generated_at":"2026-05-16T05:57:41.719383+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Ultragenyx resubmits UX111 BLA for Sanfilippo type A to FDA; PDUFA expected Q3 2026","bullets":["Resubmitted BLA for UX111 gene therapy for Sanfilippo type A on Jan 30, 2026.","Submission addresses CMC observations from July 2025 CRL and includes additional year of clinical follow-up data.","FDA previously acknowledged robust neurodevelopmental data; updated data show durable treatment effect and acceptable safety.","PDUFA action date expected within a month; six-month review period suggests PDUFA in Q3 2026.","If approved, UX111 would be the first approved therapy for Sanfilippo syndrome type A."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-030590","json":"https://secwatch.observer/filing/0001193125-26-030590.json","markdown":"https://secwatch.observer/filing/0001193125-26-030590.md","text":"https://secwatch.observer/filing/0001193125-26-030590.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526030590/0001193125-26-030590-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526030590/rare-20260130.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T05:57:41.719383+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"}