{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-072119","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2024-06-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:18.772991+00:00","generated_at":"2026-06-01T04:49:34.926531+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Ultragenyx and Mereo report setrusumab cuts fracture rate 67% and boosts BMD 22% in OI Phase 2","bullets":["Median annualized fracture rate reduced 67% from 0.72 to 0.00 (p=0.0014) over mean 16 months in 24 patients.","Lumbar spine BMD increased 22% from baseline at month 12 (p<0.0001); Z-score normalized from -1.73 to -0.49.","No treatment-related serious adverse events or hypersensitivity reactions; most common AEs: infusion-related events, headache.","Phase 3 portion of Orbit study enrolled 158 patients; Cosmic study enrolled 69 patients; 14-month data to be presented at future meeting."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-072119","json":"https://secwatch.observer/filing/0000950170-24-072119.json","markdown":"https://secwatch.observer/filing/0000950170-24-072119.md","text":"https://secwatch.observer/filing/0000950170-24-072119.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000095017024072119/0000950170-24-072119-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000095017024072119/rare-20240611.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T04:49:34.926531+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"}