{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-090616","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2025-06-27T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.567206+00:00","generated_at":"2026-05-18T15:48:48.759253+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Ultragenyx receives FDA Breakthrough Therapy Designation for GTX-102 in Angelman syndrome","bullets":["FDA granted Breakthrough Therapy Designation for GTX-102 (apazunersen) for Angelman syndrome.","Based on Phase 1/2 study in 74 patients (4-17 years) with full maternal UBE3A deletion showing consistent developmental gains.","Designation aims to expedite development and review; may enable rolling submission and enhanced FDA guidance.","Positive data shows rapid, sustained improvements across multiple symptom domains over up to three years."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-090616","json":"https://secwatch.observer/filing/0000950170-25-090616.json","markdown":"https://secwatch.observer/filing/0000950170-25-090616.md","text":"https://secwatch.observer/filing/0000950170-25-090616.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000095017025090616/0000950170-25-090616-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000095017025090616/rare-20250627.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T15:48:48.759253+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"}