{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-357185","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2026-08-19T21:24:44+00:00","discovered_at":"2026-08-19T21:26:13.462373+00:00","generated_at":"2026-08-19T21:26:47.484991+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Ultragenyx wins FDA accelerated approval for GENGLYCOS (DTX401) in GSDIa","bullets":["FDA granted accelerated approval for GENGLYCOS (pariglasgene brecaparvovec-opnr) in GSDIa patients aged 8+.","Approval based on Phase 3 GlucoGene: 46 participants, cornstarch requirement reduction at Week 48 (p<0.001).","Efficacy data from 44 mITT (DTX401 n=20, placebo n=24); crossover followed to Week 96/144.","Post-marketing DMP: 2-year data from 50 treated and 20 control patients; 10-year total follow-up.","Control group consists of patients with anti-AAV8 antibodies ineligible for treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-357185","json":"https://secwatch.observer/filing/0001193125-26-357185.json","markdown":"https://secwatch.observer/filing/0001193125-26-357185.md","text":"https://secwatch.observer/filing/0001193125-26-357185.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526357185/0001193125-26-357185-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000119312526357185/rare-20260819.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-19T21:26:47.484991+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"}