On November 6, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the third quarter ended September 30, 2025, and provided an overview of recent developments.
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"Our launch of ZUSDURI, the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, continues to gain momentum," said Liz Barrett, President and Chief Executive Officer of UroGen. "Despite slower than anticipated new patient starts, we are encouraged by the patient demand reflected in our patient enrollment forms. Strong enthusiasm and engagement from urologists, growing physician awareness, and broad reimbursement coverage are expanding patient access. Early launch indicators reflect robust interest and confidence in ZUSDURI’s clinical value, reinforcing our belief in the significant commercial opportunity ahead and our ability to fully capitalize on it. The strong complete-response rate for UGN-103 and the FDA’s agreement with our NDA submission plan supports our strategy for the next-generation medicines that are expected to enhance supply, improve manufacturing and preparation efficiencies and provide opportunity for lifecycle extensions. With a strong financial position, we are committed to driving a successful launch of ZUSDURI and advancing our pipeline in ways that deliver lasting impact for patients and long-term value for shareholders."
Q3 2025 and Recent Business Highlights:
ZUSDURI (mitomycin) for intravesical solution:
Following U.S. Food and Drug Administration (FDA) approval on June 12, 2025, UroGen launched ZUSDURI (formerly UGN-102), the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), marking a major milestone in bladder cancer care.
ZUSDURI was assigned a unique, permanent Healthcare Common Procedure Coding System J-code (J9282) by the Centers for Medicare & Medicaid Services. The J-code is expected to be effective January 1, 2026.
ZUSDURI is now broadly accessible to patients through Commercial, Medicare, and Medicaid insurance programs, with open access for more than 95% of covered lives and approximately 296 million eligible patients.
ZUSDURI achieved net product revenue of $1.8 million in Q3 2025; October 2025 preliminary demand revenue estimate of $4.5 million demonstrates accelerating commercial uptake and growing physician adoption.
From launch on July 1, 2025 through October 31, 2025, UroGen reports:
592 activated sites of care
54 unique ZUSDURI prescribers
16 repeat ZUSDURI prescribers
The article "Review of UGN-102: A Reverse Thermal Gel Containing Mitomycin for the Treatment of Recurrent, Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer" was published in Reviews in Urology and highlights durable efficacy and manageable safety profile of ZUSDURI in patients with recurrent LG-IR-NMIBC.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC)
Generated net product revenue of $25.7 million in the quarter ended September 30, 2025, compared to $25.2 million (which included CREATES Act sales of $2.6 million) reported for same quarter in 2024. Underlying demand revenue grew by approximately 13% year-over-year.
Next-generation novel mitomycin-based formulation for urothelial cancers
Enrollment is complete in the ongoing Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC. UroGen reported a three-month complete response rate (CRR) of 77.8% (95% CI, 68.3% to 85.5%), consistent with results from the ENVISION clinical trial.
The FDA agreed with the regulatory plan to submit an NDA based on the data from the single-arm Phase 3 UTOPIA trial to support potential approval of UGN-103. UroGen anticipates submitting an NDA for UGN-103 in the second half of 2026 with potential approval anticipated in 2027.
UGN-103 is a next generation product designed to offer certain improvements over ZUSDURI (mitomycin) for intravesical solution, including a shorter manufacturing process and simplified reconstitution procedure. UGN-103 combines UroGen’s RTGel technology with a novel mitomycin formulation licensed from medac GmbH. For more information on the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing. UGN-104 is an investigational next-generation mitomycin product for LG-UTUC. Like UGN-103, UGN-104 combines UroGen’s RTGel technology with a novel mitomycin formulation licensed from medac GmbH.
UGN-301 (zalifrelimab), an anti-CTLA4 antibody for use in high-grade non-muscle invasive bladder cancer
UroGen has made the strategic decision to discontinue development of UGN-301 (zalifrelimab) following completion of its Phase 1 dose escalation study. While the study confirmed proof of concept for RTGel as a viable platform for local delivery of complex immunotherapies, UGN-301’s overall clinical profile did not meet UroGen’s internal benchmarks for advancement to Phase 2. The program achieved key proof of concept objectives, including sustained bladder exposure with minimal systemic absorption and was generally well tolerated, demonstrating the ability to mitigate CTLA-4–related toxicities, and encouraging efficacy signals. These findings further reinforce the versatility and potential of RTGel technology to enable localized delivery of immunotherapy candidates.
UroGen provided notice to Agenus Inc. of termination for convenience of the License Agreement between the parties. In accordance with the terms of the agreement, termination will become effective upon the later of (i) expiration of the 180-day notice period, or (ii) completion of all required wind-down activities, including the delivery of any Agenus Improvements as defined in the License Agreement.
UGN-501 (investigational next-gen oncolytic virus) for use in high-grade non-muscle invasive bladder cancer (
UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus therapy being developed as a locally administered treatment for bladder cancer and other specialty cancers. Investigational New Drug (IND)-enabling studies are currently ongoing, with the goal of submitting an IND and initiating a Phase 1 trial in 2026.
Third quarter 2025 Financial Results
Revenue: Total revenues for the third quarter ended September 30, 2025 were $27.5 million. JELMYTO generated net product revenue of $25.7 million for the quarter ended September 30, 2025, compared to $25.2 million (which included $2.6 million of CREATES Act sales) in the same period of 2024, reflecting approximately 13% underlying year-over-year demand driven revenue growth. ZUSDURI achieved net product revenue of $1.8 million in its first quarter on the market, with October 2025 preliminary demand revenue estimate of $4.5 million demonstrating growing early commercial momentum.
R&D Expenses: Research and development (R&D) expenses for the third quarter of 2025 were $14.0 million, including non-cash share-based compensation expense of $0.7 million as compared to $11.4 million, including non-cash share-based compensation expense of $0.6 million, for the same period in 2024. The increase in R&D expenses of $2.6 million was primarily driven by costs associated with the Phase 3 UTOPIA trial for UGN-103, partially offset by lower clinical trial costs, manufacturing costs, and regulatory expenses in connection with ZUSDURI.
SG&A Expenses: Selling, general and administrative expenses (SG&A) for the third quarter of 2025 were $37.6 million, including non-cash share-based compensation expense of $2.3 million. This compares to $28.9 million, including non-cash share-based compensation expense of $2.9 million, for the same period in 2024. The increase in SG&A expenses of $8.7 million was primarily driven by ZUSDURI commercial launch activities as well as an increase in overall commercial operation costs.
Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the third quarter of 2025, compared to $5.9 million in the same period in 2024. The decrease was primarily driven by changes in underlying assumptions for remeasuring the effective rate.
Interest Expense on Long-Term Debt: Interest expense related to the $125 million term loan facility with funds managed by Pharmakon Advisors was $3.4 million in the third quarter of 2025, compared to $2.7 million in the same period in 2024. The increase was primarily attributable to the interest expense on the third tranche of the loan that was funded in September 2024.
Net Loss: UroGen reported a net loss of $33.3 million or ($0.69) per basic and diluted share in the third quarter of 2025 compared with a net loss of $23.7 million or ($0.51) per basic and diluted share in the same period in 2024.
Cash and Equivalents: As of September 30, 2025, cash, cash equivalents and marketable securities totaled $127.4 million.
For further details on the Company’s financials, refer to Form 10-Q, filed with the SEC.
2025 JELMYTO Revenue and Company Operating Expense Guidance: Guidance for full-year 2025 net product revenues for JELMYTO remains unchanged and is expected to be in the range of $94 to $98 million. This implies a year-over-year growth rate of approximately 8% to 12% over the $87.4 million in demand driven JELMYTO sales in 2024, which excludes the $3.0 million in CREATES Act sales reported in 2024. Continue to expect full-year 2025 operating expenses to be in the range of $215 to $225 million, including non-cash share-based compensation expense of $11 million to $14 million.
Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.
(Press release, UroGen Pharma, NOV 6, 2025, View Source [SID1234659591])