{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-332422","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2025-12-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.604140+00:00","generated_at":"2026-05-16T12:06:06.117915+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Ultragenyx's setrusumab fails Phase 3 primary endpoints in OI; expense cuts planned","bullets":["Orbit and Cosmic studies did not meet primary endpoint of reducing annualized clinical fracture rate versus comparators.","Both studies achieved secondary endpoint of significant improvement in bone mineral density (BMD).","Company plans to implement significant expense reductions; evaluating next steps for the program.","Safety profile unchanged; no new safety signals observed."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-332422","json":"https://secwatch.observer/filing/0001193125-25-332422.json","markdown":"https://secwatch.observer/filing/0001193125-25-332422.md","text":"https://secwatch.observer/filing/0001193125-25-332422.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000119312525332422/0001193125-25-332422-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000119312525332422/rare-20251229.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:06:06.117915+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"}