UroGen (URGN) reported fourth-quarter 2025 revenue of $18.3 million, reflecting a 12% year-over-year increase, driven by continued adoption of its Bladder Cancer Therapy, RethyX. The company also highlighted progress in its clinical pipeline, including Phase 2 data from a novel intravesical formulation.
- UroGen reported Q4 2025 revenue of $18.3 million, up 12% YoY.
- RethyX prescriptions increased 18% year-over-year in Q4 2025.
- Net loss widened to $24.7 million ($0.35 per share) in Q4 2025.
- Phase 2 trial of URGN-301 showed 42% reduction in bladder cancer recurrence at 12 months.
- Pre-IND submission for URGN-301 expected by mid-2026.
- URGN stock closed at $11.42 on March 1, 2026, up 0.7% post-earnings.
UroGen Inc. (URGN) delivered $18.3 million in revenue during the fourth quarter of 2025, up from $16.3 million in the same period of 2024, marking a 12% year-over-year growth. The increase was primarily attributed to expanded commercialization of RethyX, its FDA-approved intravesical therapy for non-muscle invasive bladder cancer (NMIBC), with prescription volumes rising 18% compared to Q4 2024. The company reported a net loss of $24.7 million for the quarter, or $0.35 per share, compared to a net loss of $21.9 million, or $0.31 per share, in the prior-year period, reflecting higher R&D and sales & marketing expenditures. The company emphasized ongoing clinical development, noting positive interim results from its Phase 2 trial of URGN-301, a next-generation intravesical drug candidate designed to improve treatment adherence and reduce recurrence rates in high-risk NMIBC patients. Data from the trial, presented at the 2026 American Urological Association Annual Meeting, showed a 42% reduction in recurrence at 12 months compared to historical controls. UroGen plans to submit a pre-IND package to the FDA by mid-2026 for URGN-301. Trading in URGN shares remained relatively stable post-earnings, with the stock closing at $11.42 on March 1, 2026, a 0.7% gain. The broader healthcare sector, as measured by the XLP ETF (XLV), gained 0.3% over the same period, while the healthcare services subsector (IHF) rose 0.5%. Analysts noted that while UroGen’s performance was solid for a small-cap biotech, the company remains dependent on continued commercial success of RethyX and execution of its pipeline strategy.