secwatch.observer — SEC 8-K summary
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Issuer:     Ultragenyx Pharmaceutical Inc. (RARE)
CIK:        0001515673
Form:       8-K
Filed at:   2024-06-12T23:59:59+00:00
Accession:  0000950170-24-072119
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Ultragenyx and Mereo report setrusumab cuts fracture rate 67% and boosts BMD 22% in OI Phase 2
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1515673/000095017024072119/0000950170-24-072119-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1515673/000095017024072119/rare-20240611.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-072119

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