{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-109570","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2025-08-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.188516+00:00","generated_at":"2026-05-17T11:53:14.944734+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Ultragenyx starts rolling BLA submission for DTX401 gene therapy in GSDIa","bullets":["Initiated rolling BLA submission to FDA for DTX401 AAV gene therapy for Glycogen Storage Disease Type Ia.","Submitted non-clinical and clinical modules; plans to complete full BLA including CMC module in Q4 2025.","BLA includes 96-week Phase 3 data showing ~60-64% reduction in daily cornstarch use from baseline.","Updates address FDA observations from prior UX111 complete response letter related to CMC and manufacturing."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-109570","json":"https://secwatch.observer/filing/0000950170-25-109570.json","markdown":"https://secwatch.observer/filing/0000950170-25-109570.md","text":"https://secwatch.observer/filing/0000950170-25-109570.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000095017025109570/0000950170-25-109570-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000095017025109570/rare-20250818.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:53:14.944734+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"}