---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-160413"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2024-06-13T23:59:59+00:00"
generated_at: "2026-06-01T04:38:05.055819+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# UroGen reports positive DOR data from Phase 3 ENVISION trial for UGN-102 in bladder cancer

## Summary
- 12-month DOR KM estimate for CR patients: 82.3% (95% CI: 75.9%-87.1%); predicted median DOR of 40 months.
- ENVISION met primary endpoint with 79.6% CR rate at 3 months; safety profile mild-to-moderate.
- Rolling NDA submission to FDA for UGN-102 to complete Q3 2024; potential acceptance Q4 2024, approval Q1/Q2 2025.
- If approved, UGN-102 would be first FDA-approved medicine for LG-IR-NMIBC; addressable market over $5B (82K patients, $16-19K/dose).
- UGN-102 offers a non-surgical alternative to TURBT; ~68% of patients have 2+ recurrences and repeated TURBT carries adverse event risks.

## SEC filing metadata
- accession: 0001193125-24-160413
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2024-06-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000119312524160413/0001193125-24-160413-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000119312524160413/d852084d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-160413
- JSON: https://secwatch.observer/filing/0001193125-24-160413.json
- Plain text: https://secwatch.observer/filing/0001193125-24-160413.txt

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