UGN-102 NDA Submission and FDA Review
UGN-102, aimed at treating intermediate risk, low-grade, non-muscle invasive bladder cancer, has been submitted for FDA review ahead of schedule, with a PDUFA target date of June 13.
Strong Phase 3 Trial Results
ENVISION Phase 3 trial data for UGN-102 showed a complete response rate of 79.6% at three months and 80.6% at 18 months, with a median duration of response not yet reached.
JELMYTO Revenue Growth
JELMYTO generated net product revenues of $90.4 million in 2024, up from $82.7 million in 2023, marking a 12% increase in underlying demand.
Acquisition of ICVB-1042
The acquisition of ICVB-1042, a next-generation oncolytic virus, aligns with UroGen's strategic focus and enhances its pipeline.
Strong Financial Position
UroGen ended 2024 with $241.7 million in cash, providing a solid foundation to continue executing strategic initiatives.