---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-200993"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2024-08-15T23:59:59+00:00"
generated_at: "2026-05-31T09:01:40.370602+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# UroGen Pharma submits NDA to FDA for UGN-102 for low-grade intermediate-risk NMIBC

## Summary
- Completed NDA submission for UGN-102 to the U.S. FDA.
- UGN-102 is intended for low-grade intermediate-risk non-muscle invasive bladder cancer treatment.
- Regulatory submission marks a key milestone toward potential approval.

## SEC filing metadata
- accession: 0001193125-24-200993
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2024-08-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000119312524200993/0001193125-24-200993-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000119312524200993/d834673d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-200993
- JSON: https://secwatch.observer/filing/0001193125-24-200993.json
- Plain text: https://secwatch.observer/filing/0001193125-24-200993.txt

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