UroGen Pharma (URGN) reported accelerating commercial traction for its recently approved bladder cancer drug Zusduri at the Cantor Fitzgerald Global Healthcare Conference on September 10, 2026, and announced it has submitted a new-drug application to the FDA for a next-generation formulation aimed at the same indication.
Zusduri revenue more than doubled in its first two quarters on the market, rising to $50 million in the second quarter of 2025 from $29.8 million in the first, a sequential increase of 67.2%. As of June 30, 2025, UroGen said it had 450 unique prescribers using the drug and that repeat prescribing had climbed to 45 percent from 40 percent over the same period.
The company expanded its sales force from 50 to 80 representatives and reported 1,400 activated treatment sites as of mid-year. More than 95 percent of covered lives have access to Zusduri, UroGen said.
Zusduri, a mitomycin treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, is administered via catheter instillation during a one-hour office visit, allowing patients to return to normal activities the same day. The standard procedure for the condition, transurethral resection of bladder tumor, typically requires anesthesia, operating-room time and recovery, and is frequently described by patients as painful.
Management estimated the addressable patient population for the indication at roughly 60,000 annually in the United States. On conservative assumptions — a 20 percent market share and a net price of $100,000 per patient — UroGen calculated a peak-sales opportunity of approximately $1.2 billion, noting the figure could exceed that estimate.
The company also provided details on UGN-103, a next-generation mitomycin gel that follows Zusduri. According to UroGen, the formulation reduces lyophilization time from three weeks to three days, cuts mixing time from 45 minutes to 15 minutes, and extends the reconstituted shelf life from seven days to multiple weeks. UroGen submitted the NDA for UGN-103 in mid-August and is targeting a mid-June 2026 PDUFA decision date. A J-code is expected January 1, 2028, and a planned adjuvant study in newly diagnosed intermediate-risk NMIBC is scheduled for 2026.
UroGen said its cash position stood at $180 million as of June 30, 2025, and stated that amount is sufficient to reach profitability. The company’s market capitalization was $2.06 billion at the time of the conference, and its stock has returned 135 percent over the past year and gained 131 percent over the prior six months, with Wall Street price targets ranging from $48 to $75.
On the pipeline front, Phase III trial enrollment for UGN-104, a next-generation product for upper tract urothelial carcinoma, is expected to conclude by the end of 2025. Phase I dose-escalation and first-patient dosing for UGN-501, an oncolytic virus program acquired in 2024, are also planned for late 2025, with Phase I data expected the following year. Operating expenses are slated to rise in the second half of 2025 to support physician education efforts.
Patent protection is extending well into the coming decades. Core patents around the RTGel platform run through January 2031, a method-of-use patent covering the low-grade intermediate-risk indication for both Zusduri and UGN-103 extends to July 2044, UGN-103 gel parameters and intellectual property run through December 2041, and medac GmbH’s composition-of-matter patent for mitomycin expires around mid-2035.
