---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-326173"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2021-11-10T23:59:59+00:00"
generated_at: "2026-06-28T10:00:35.437433+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# UroGen to start new Phase 3 study for UGN-102; stops ATLAS enrollment

## Summary
- New single-arm Phase 3 pivotal study for UGN-102 in low-grade intermediate-risk non-muscle invasive bladder cancer expected to start early 2022, enrolling ~220 patients at 90 sites.
- ATLAS trial enrollment halted; patients already enrolled may remain until completion.
- Company believes new study design increases regulatory success probability; NDA submission for UGN-102 remains on track for 2024.
- UGN-301: non-human primate toxicity studies underway; multi-arm Phase 1 study planned early 2022 with combination approaches.

## SEC filing metadata
- accession: 0001193125-21-326173
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2021-11-10T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000119312521326173/0001193125-21-326173-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000119312521326173/d244400d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-326173
- JSON: https://secwatch.observer/filing/0001193125-21-326173.json
- Plain text: https://secwatch.observer/filing/0001193125-21-326173.txt

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