---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-033466"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2025-11-06T23:59:59+00:00"
generated_at: "2026-05-16T23:46:05.569451+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# UroGen Q3: ZUSDURI rev $1.8M, Oct estimate $4.5M; JELMYTO +13% YoY; net loss $33.3M

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-25-033466
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2025-11-06T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000143774925033466/0001437749-25-033466-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000143774925033466/urgn20251031_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-033466
- JSON: https://secwatch.observer/filing/0001437749-25-033466.json
- Plain text: https://secwatch.observer/filing/0001437749-25-033466.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.