{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-072414","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2024-06-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.773272+00:00","generated_at":"2026-06-01T04:49:39.428018+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA agrees CSF heparan sulfate as surrogate endpoint for UX111 accelerated approval BLA in MPS IIIA","bullets":["FDA agreed cerebral spinal fluid heparan sulfate is a reasonable surrogate endpoint supporting accelerated approval for UX111 gene therapy in Sanfilippo syndrome type A (MPS IIIA).","Company intends to file BLA late 2024 or early 2025 after a pre-BLA meeting with the FDA.","BLA filing will rely on data from the ongoing pivotal Transpher A study and long-term follow-up; results were presented at WORLDSymposium."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-072414","json":"https://secwatch.observer/filing/0000950170-24-072414.json","markdown":"https://secwatch.observer/filing/0000950170-24-072414.md","text":"https://secwatch.observer/filing/0000950170-24-072414.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000095017024072414/0000950170-24-072414-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000095017024072414/rare-20240612.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T04:49:39.428018+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"}