{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-337099","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2025-12-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.604358+00:00","generated_at":"2026-05-16T11:58:59.574707+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Ultragenyx completes rolling BLA submission for DTX401 gene therapy to FDA for GSDIa","bullets":["BLA submission for DTX401 (pariglasgene brecaparvovec) completed for glycogen storage disease type Ia; based on 52 treated patients with up to 6 years follow-up.","Phase 3 GlucoGene study showed significant reductions in daily cornstarch intake while maintaining euglycemia and improved quality of life.","Rolling review began with non-clinical/clinical modules in August 2025; CMC module now submitted to complete the package.","DTX401 was well tolerated with an acceptable safety profile per the press release."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-337099","json":"https://secwatch.observer/filing/0001193125-25-337099.json","markdown":"https://secwatch.observer/filing/0001193125-25-337099.md","text":"https://secwatch.observer/filing/0001193125-25-337099.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000119312525337099/0001193125-25-337099-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000119312525337099/rare-20251230.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:58:59.574707+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"}