secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2025-11-06T23:59:59+00:00
Accession:  0001437749-25-033466
Event type: earnings
Sentiment:  positive
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

UroGen Q3: ZUSDURI rev $1.8M, Oct estimate $4.5M; JELMYTO +13% YoY; net loss $33.3M
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- ZUSDURI achieved net product revenue of $1.8M in Q3; October 2025 preliminary demand revenue estimate of $4.5M, with 592 activated sites and 54 prescribers since July launch.
- JELMYTO net revenue $25.7M (+13% YoY underlying demand growth); full-year JELMYTO guidance unchanged at $94-98M, op expenses $215-225M.
- Net loss of $33.3M ($0.69/share) vs $23.7M ($0.51) in Q3 2024; cash $127.4M as of Sept 30, 2025.
- UGN-103 Phase 3 UTOPIA shows 77.8% CRR; FDA agrees to NDA submission plan; NDA expected H2 2026 with potential approval 2027.
- UGN-301 (zalifrelimab) development discontinued; UroGen terminates license with Agenus.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000143774925033466/0001437749-25-033466-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000143774925033466/urgn20251031_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-25-033466

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