{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-084254","form_type":"8-K","ticker":"RARE","cik":"0001515673","company_name":"Ultragenyx Pharmaceutical Inc.","filed_at":"2024-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.329244+00:00","generated_at":"2026-05-31T20:12:05.592748+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Ultragenyx aligns with FDA on Phase 3 design for GTX-102 in Angelman syndrome","bullets":["FDA alignment on EoP2 meeting for GTX-102; Phase 3 trial to enroll ~120 UBE3A deletion patients.","Primary endpoint: Bayley-4 cognitive raw score; 48-week double-blind, sham-controlled design.","Patients in control arm eligible to roll over to treatment after double-blind period.","EMA accepted Phase 3 design under PRIME; PMDA meeting expected in coming weeks.","Plans for open-label study to evaluate GTX-102 in other Angelman genotypes and age groups."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-084254","json":"https://secwatch.observer/filing/0000950170-24-084254.json","markdown":"https://secwatch.observer/filing/0000950170-24-084254.md","text":"https://secwatch.observer/filing/0000950170-24-084254.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1515673/000095017024084254/0000950170-24-084254-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1515673/000095017024084254/rare-20240717.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:12:05.592748+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"}