secwatch.observer — SEC 8-K summary
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Issuer:     Ultragenyx Pharmaceutical Inc. (RARE)
CIK:        0001515673
Form:       8-K
Filed at:   2023-10-16T23:59:59+00:00
Accession:  0001193125-23-256537
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Ultragenyx reports prelim Q3 rev $96-100M; UX143 cuts fractures 67% in Phase 2
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- Prelim Q3 total rev $96-100M; Crysvita $74-76M (impacted by inventory shift to KKC); cash $525M.
- Setrusumab (UX143) cut annualized fracture rate 67% (p=0.042) in Phase 2; BMD +13-16% at 6 months.
- GTX-102 for Angelman: clinically meaningful improvements vs natural history; no new SAEs since Nov 2022.
- UX701 for Wilson: 4/5 low-dose patients tapering off chelators; 2 completely off standard therapy.
- Gene therapy: DTX401 Phase 3 fully enrolled; UX111 fully enrolled; DTX301 enrollment expected H1 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1515673/000119312523256537/0001193125-23-256537-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1515673/000119312523256537/d548890d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-256537

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