---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-276676"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2023-11-14T23:59:59+00:00"
generated_at: "2026-06-08T03:42:30.255824+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# UroGen Q3 JELMYTO revenue $20.9M (+30% YoY); FDA agrees to rolling NDA for UGN-102

## Summary
- JELMYTO net product revenue $20.9M in Q3 2023, up ~30% from $16.1M in Q3 2022.
- FDA agreed to rolling NDA for UGN-102 in LG-IR-NMIBC starting Jan 2024; ENVISION trial showed 79.2% CRR at 3 months.
- Net loss improved to $21.9M ($0.68/sh) from $25.8M ($1.13/sh) in Q3 2022.
- Cash and marketable securities $153.9M as of Sep 30, 2023; FY 2023 revenue guidance reiterated at $76-86M.
- ATLAS trial met primary endpoint; 55% reduction in risk of recurrence/progression/death.

## SEC filing metadata
- accession: 0001193125-23-276676
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2023-11-14T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000119312523276676/0001193125-23-276676-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000119312523276676/d437259d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-276676
- JSON: https://secwatch.observer/filing/0001193125-23-276676.json
- Plain text: https://secwatch.observer/filing/0001193125-23-276676.txt

## Key facts
- Earnings Releases
  UroGen Pharma Ltd. reported the third quarter ended September 30, 2023 results: revenue $20.9 million, net income a net loss of $21.9 million, EPS basic and diluted net loss per ordinary share of $0.68. Guidance reaffirmed.
  - Period: the third quarter ended September 30, 2023
  - Revenue: $20.9 million
  - Net income: a net loss of $21.9 million
  - EPS: basic and diluted net loss per ordinary share of $0.68
  - Guidance: reaffirmed
  - Result: reported results
  source text: --- EX-99.1 (EX-99.1) --- EX-99.1 Exhibit 99.1 UroGen Pharma Reports Third Quarter 2023 Financial Results • Continued strong growth with JELMYTO ® net product revenues of $20.9 million in Q3 2023; an increase of ~30% from the same period last year • Agreement with United States Food & Drug Administration (FDA) to proceed with rolling New Drug Application (NDA)
  evidence_url: https://www.sec.gov/Archives/edgar/data/1668243/000119312523276676/0001193125-23-276676-index.htm

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