---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-025242"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2025-08-07T23:59:59+00:00"
generated_at: "2026-05-17T17:45:32.223599+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# UroGen reports Q2 loss of $49.9M; launches ZUSDURI after June FDA approval

## Summary
- ZUSDURI (mitomycin) FDA-approved June 12 for recurrent LG-IR-NMIBC; now commercially available.
- JELMYTO Q2 net revenue $24.2M (+11% vs Q2 2024); FY guidance $94-98M unchanged.
- Net loss $49.9M ($1.05/share) vs $33.4M ($0.82) in Q2 2024; operating loss $41.4M.
- Cash and marketable securities $161.6M at June 30, 2025.
- Enrollment complete in Phase 3 UTOPIA trial for next-gen mitomycin UGN-103.

## SEC filing metadata
- accession: 0001437749-25-025242
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2025-08-07T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000143774925025242/0001437749-25-025242-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000143774925025242/urgn20250804_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-025242
- JSON: https://secwatch.observer/filing/0001437749-25-025242.json
- Plain text: https://secwatch.observer/filing/0001437749-25-025242.txt

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