UGN-102 FDA Review Progress
UGN-102 is in the final stages of FDA review with a PDUFA target date of June 13th. An ODAC meeting is scheduled for May 21st, and the company is well-prepared to present a strong case for approval.
Strong Clinical Trial Results
Updated data from the pivotal ENVISION trial showed that 80.6% of patients who achieved a complete response at three months remained in response at 18 months.
Commercial Readiness and Market Opportunity
UGN-102 represents a transformative growth opportunity, targeting an addressable population of approximately 60,000 patients annually and a market opportunity of over $5 billion.
JELMYTO Revenue Growth
Reported $20.3 million in first-quarter sales, an 8% year-over-year growth compared to the first quarter of 2024, driven by underlying demand growth of 12%.
Strong Financial Position
Supported by a strong balance sheet with over $200 million in cash, cash equivalents, and marketable securities as of March 31st, 2025.