UroGen PDUFA date June 13

 

• UGN-102 Pivotal ENVISION trial demonstrated an 18-month DOR of 80.6% (95% CI: 74.0, 85.7), by Kaplan-Meier estimate, for patients who achieved a complete response (CR) at three months after the first instillation of UGN-102
• New drug application (NDA) for UGN-102 under review by the FDA; Prescription Drug User Fee Act (PDUFA) target action date set for June 13, 2025
• Acquired a next-generation investigational oncolytic virus (ICVB-1042) and announced multiple strategic research collaborations in support of long-term growth strategy
• JELMYTO® achieved net product revenue of $90.4 million in 2024, compared with $82.7 million in 2023, driven by underlying demand revenue growth of 12% for 2024 and 15% for Q4 2024
• $241.7 million in cash, cash equivalents and marketable securities as of December 31, 2024
• Conference call and webcast to be held today at 10:00 AM ET

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

https://www.businesswire.com/news/home/20250310157926/en/UroGen-Pharma-Reports-Fourth-Quarter-and-Full-Year-2024-Financial-Results-and-Announces-Updated-18-Month-Duration-of-Response-DOR-of-80.6-from-the-Phase-3-ENVISION-Trial-of-UGN-102