UroGen Reports $68.0 Million of ZUSDURI Revenue and Provides Third Quarter 2026 Financial Results and Highlights
Key Highlights
- ➤ZUSDURI revenue reached $68.0 million, up 35% quarter-over-quarter
- ➤Total revenue rose to $89.0 million from $27.5 million year-over-year
- ➤FDA accepted UGN-103 NDA; PDUFA target date set for June 14, 2027
- ➤JELMYTO revenue fell to $21.0 million from $25.7 million year-over-year
- ➤2026 JELMYTO revenue guidance reduced to approximately $90 million
- ➤UGN-501 Phase 1 trial dosed its first patient in November 2026
Expert Statements
Liz Barrett, President and Chief Executive Officer of UroGen
“We delivered another strong quarter of execution, with ZUSDURI continuing to scale as growing repeat utilization, expanding community adoption, and broader physician engagement reinforce our confidence in the long-term commercial opportunity”
Liz Barrett, President and Chief Executive Officer of UroGen
“At the same time, we are strengthening the durability of our business through the advancement of UGN-103, which aims to build on the success of ZUSDURI and create opportunities to expand into additional patient populations.”
Liz Barrett, President and Chief Executive Officer of UroGen
“The U.S. Food and Drug Administration’s (FDA’s) acceptance of the UGN-103 New Drug Application (NDA) in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), together with our newly issued patent providing coverage into July 2044, further reinforce the long-term revenue potential of our bladder cancer portfolio.”
Liz Barrett, President and Chief Executive Officer of UroGen
“Looking ahead, our planned expansion into high-grade NMIBC with UGN-103, advancement of UGN-501 into the clinic, and strategic collaboration with IntraGel provide multiple opportunities for future growth.”
Liz Barrett, President and Chief Executive Officer of UroGen
“Together, we believe these achievements position UroGen to build a sustainable growth company and create meaningful long-term shareholder value.”
* ZUSDURI(®) generated $68.0 million in revenue in the third quarter of 2026, representing 35% quarter-over-quarter growth * The FDA accepted UroGen’s NDA for UGN-103 (next-generation novel mitomycin-based formulation) for review; PDUFA goal date set for June 14, 2027 * Announced first patient dosed in the UGN-501 Phase 1 trial * Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., Nov. 04, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2026, and provided an overview of recent developments.
“We delivered another strong quarter of execution, with ZUSDURI continuing to scale as growing repeat utilization, expanding community adoption, and broader physician engagement reinforce our confidence in the long-term commercial opportunity,” said Liz Barrett, President and Chief Executive Officer of UroGen. “At the same time, we are strengthening the durability of our business through the advancement of UGN-103, which aims to build on the success of ZUSDURI and create opportunities to expand into additional patient populations. The U.S. Food and Drug Administration’s (FDA’s) acceptance of the UGN-103 New Drug Application (NDA) in low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), together with our newly issued patent providing coverage into July 2044, further reinforce the long-term revenue potential of our bladder cancer portfolio. Looking ahead, our planned expansion into high-grade NMIBC with UGN-103, advancement of UGN-501 into the clinic, and strategic collaboration with IntraGel provide multiple opportunities for future growth. Together, we believe these achievements position UroGen to build a sustainable growth company and create meaningful long-term shareholder value.”
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