secwatch.observer — SEC 8-K summary
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Issuer:     Ultragenyx Pharmaceutical Inc. (RARE)
CIK:        0001515673
Form:       8-K
Filed at:   2025-07-09T23:59:59+00:00
Accession:  0000950170-25-094806
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Ultragenyx's UX143 Phase 3 Orbit passes DMC safety review; final analysis year-end 2025
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- DMC confirms acceptable safety profile for UX143 in pediatric/young adult OI patients; study continues to final analysis.
- Final analysis of Phase 3 Orbit trial expected around end of 2025, with statistical threshold p<0.04.
- Safety in younger patients consistent with prior studies; no data from Cosmic study analyzed at interim.
- Patients continue dosing; final analyses after at least 18 months therapy.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1515673/000095017025094806/0000950170-25-094806-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1515673/000095017025094806/rare-20250709.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-094806

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer