secwatch.observer — SEC 8-K summary
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Issuer:     Ultragenyx Pharmaceutical Inc. (RARE)
CIK:        0001515673
Form:       8-K
Filed at:   2024-11-05T23:59:59+00:00
Accession:  0000950170-24-121459
Event type: earnings
Sentiment:  positive
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Ultragenyx Q3 revenue $139M (+42% YoY); Breakthrough Therapy for setrusumab; DTX401 crossover 62% cornstarch reduction
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- Total revenue $139M, up 42% YoY; Crysvita $98M (+31%), Dojolvi $21M (+29%), Evkeeza $11M.
- Net loss $134M ($1.40/share) vs $160M ($2.23) YoY; operating cash burn $67M in Q3.
- FY2024 guidance reaffirmed: total revenue $530-550M, Crysvita upper end $375-400M, Dojolvi $75-80M.
- Setrusumab (UX143) granted FDA Breakthrough Therapy for osteogenesis imperfecta based on 67% fracture reduction.
- DTX401 Phase 3 crossover patients showed 62% mean cornstarch reduction at week 30; BLA submission planned mid-2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1515673/000095017024121459/0000950170-24-121459-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1515673/000095017024121459/rare-20241105.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-121459

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