---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-140339"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2025-06-13T23:59:59+00:00"
generated_at: "2026-05-19T08:31:12.792845+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# FDA approves UroGen Pharma's ZUSDURI (mitomycin) for recurrent LG-IR-NMIBC

## Summary
- FDA approved ZUSDURI (mitomycin) for adults with recurrent low-grade intermediate-risk NMIBC on June 12, 2025.
- Phase 3 ENVISION trial: 78% achieved complete response at 3 months; 79% of those maintained at 12 months.
- Expected commercial availability in the U.S. on or around July 1, 2025.
- Common adverse reactions include increased creatinine, dysuria, hematuria; serious reactions in 12% of patients.
- Post-marketing commitment: ongoing ENVISION trial to further characterize clinical benefit; annual duration of response updates.

## SEC filing metadata
- accession: 0001193125-25-140339
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2025-06-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000119312525140339/0001193125-25-140339-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000119312525140339/d98388d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-140339
- JSON: https://secwatch.observer/filing/0001193125-25-140339.json
- Plain text: https://secwatch.observer/filing/0001193125-25-140339.txt

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