JELMYTO achieved $21.7 million in revenue in Q1 2026, representing year-over-year growth of 7%
Continued advancement of next-generation pipeline, UGN-103 on track for NDA submission in the second half of 2026; six-month durability data expected in mid-2026
UroGen to host Key Opinion Leader (KOL) panel highlighting real-world experience with ZUSDURI at the American Urological Association (AUA) annual meeting on May 17th at 8:30 AM ET
Conference call and webcast to be held today at 10:00 AM ET
PRINCETON, N.J., May 06, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2026, and provided an overview of recent developments.
"2026 is off to a strong start, with expanding usage of ZUSDURI™ (mitomycin) for intravesical solution and clear acceleration across key commercial indicators, including prescriber trial and adoption," said Liz Barrett, President and Chief Executive Officer of UroGen. "These trends reflect growing clinical confidence in ZUSDURI as a primary, non-surgical therapy for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The early launch momentum is now translating into meaningful revenue growth, providing early validation of our commercial model and reinforcing the blockbuster potential for ZUSDURI. In parallel, we continue to advance our broader pipeline, including next generation products UGN-103 in LG-IR-NMIBC and UGN-104 in low-grade upper tract urothelial carcinoma (LG-UTUC), as well as UGN-501, our investigational, potentially best-in-class, next-generation oncolytic virus. With this momentum, we are well positioned to execute our long-term growth strategy and continue to expand our leadership position in uro-oncology."
Q1 2026 and Recent Business Highlights:
ZUSDURI (mitomycin) for intravesical solution:
Commercial launch of ZUSDURI continues to accelerate, following its U.S. FDA-approval as the first and only FDA-approved medicine for adults with recurrent LG-IR-NMIBC.
The permanent Healthcare Common Procedure Coding System Level II J Code (J9282) became effective on January 1, 2026 and has enabled broader adoption by improving reimbursement clarity and confidence across both hospital and community settings.
ZUSDURI achieved net product revenue of $29.2 million in the first quarter of 2026, representing 109% quarter-over-quarter growth. The accelerating growth trend in prescribers, particularly repeat prescribers, reflects increasing health care provider confidence and successful integration of ZUSDURI into routine urology practice. As of March 31, 2026, UroGen reported:
972 activated sites of care
256 unique ZUSDURI prescribers
103 repeat ZUSDURI prescribers
Updated results from the Phase 3 ENVISION trial evaluating ZUSDURI were published online ahead of print in the Journal of Urology. The publication reported that patients who achieved a complete response (CR) three months after the first instillation of ZUSDURI had a 72.2% probability of remaining event-free 24 months after CR (95% CI: 64.1%, 78.8%) as determined by Kaplan-Meier analysis.
JELMYTO (mitomycin) for pyelocalyceal solution in LG-UTUC:
Generated net product revenue of $21.7 million in the quarter ended March 31, 2026, an increase of approximately 7% over the $20.3 million reported for first quarter of 2025.
Next-generation novel mitomycin-based formulations for urothelial cancer
UroGen plans to submit a New Drug Application (NDA) for UGN-103 (mitomycin) for recurrent LG-IR-NMIBC in the second half of 2026 with potential FDA approval in 2027. The FDA has agreed with the Company's regulatory plan to submit the NDA based on the data from the Phase 3 UTOPIA trial. Top line results from UTOPIA were reported in November 2025, demonstrating a 77.8% three-month CR rate (95% CI, 68.3%, 85.5%). For more information on the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
UGN-103 is a next-generation mitomycin product designed to offer improvements over ZUSDURI, including a shorter manufacturing process and simplified reconstitution procedure. It combines UroGen's RTGel® technology with a novel mitomycin formulation licensed from medac. UroGen continues to evaluate lifecycle management and pipeline expansion opportunities, including potential applications in high-grade NMIBC settings and adjuvant use of UGN-103 in IR-NMIBC patients.
The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing and is expected to be fully enrolled by the end of 2026. UGN-104 is a next-generation mitomycin product for LG-UTUC. For more information on the UGN-104 Phase 3 trial (UT002), refer to https://clinicaltrials.gov/study/NCT06774131.
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 being developed as a locally administered cancer treatment. Investigational New Drug (IND)-enabling studies are nearing completion, and UroGen plans to submit an IND in the second quarter of 2026 and initiate a Phase 1 clinical trial in NMIBC by year end. Nonclinical data to date demonstrate cytotoxic activity across a panel of bladder cancer cell lines representing a broad range of tumor stages and grades. The Phase 1 trial will initially evaluate aqueous intravesical administration of UGN-501, and UroGen plans to evaluate delivery using its proprietary RTGel technology, which may enable prolonged dwell time and enhanced local activity. The initial focus is bladder cancer with the potential to expand into additional tumor types beyond the genitourinary system.
Expanded Debt Facility with Pharmakon Advisors
In February 2026, UroGen entered into an amended and restated loan agreement with Pharmakon Advisors for two additional tranches of senior secured term loans. The first tranche of $200 million was funded at closing to refinance the existing $125 million loan facility and provide additional non-dilutive capital. A second tranche of $50 million may be drawn at the Company's option no later than June 30, 2027, subject to customary conditions. All outstanding loans with Pharmakon Advisors will accrue interest at a fixed rate of 8.25% and be repaid in four equal quarterly payments commencing in the second quarter of 2030. All outstanding loans with Pharmakon Advisors can be prepaid in whole at UroGen's discretion at any time, subject to prepayment premiums, make-whole amounts, as applicable, and fees.
American Urological Association Key Opinion Leader Panel to Showcase Real-World Experience with ZUSDURI
UroGen will host a KOL panel at the upcoming AUA Annual Meeting focused on real-world experience with ZUSDURI, including patient selection, workflow integration, treatment patterns, and patient outcomes. The event will feature leading urologists highlighting the role of ZUSDURI as a primary, non-surgical treatment option in recurrent low-grade intermediate-risk NMIBC and will be webcast and accessible through the Company's website. To register click here.
First quarter 2026 Financial Results
Revenue: Total revenue was $51.0 million in the first quarter ended March 31, 2026, compared with $20.3 million in the first quarter of 2025. Year-over-year revenue growth of 152% was primarily driven by the commercial launch of ZUSDURI and JELMYTO revenue growth.
Research and Development (R&D) Expenses: R&D expenses were $15.6 million in the first quarter of 2026, including non-cash share-based compensation expense of $0.8 million. This compares to $19.9 million, including non-cash share-based compensation expense of $0.6 million, for the same period in 2025. The decrease in R&D expenses was primarily attributable to the acquisition of UGN-501 in the first quarter of 2025 and ZUSDURI manufacturing costs, which were recognized as R&D expense in the first quarter of 2025 prior to receiving FDA approval.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $51.5 million in the first quarter of 2026, including non-cash share-based compensation expense of $3.9 million. This compares to $35.0 million, including non-cash share-based compensation expense of $2.5 million, for the same period in 2025. The increase in SG&A expenses was primarily attributable to ZUSDURI commercial activities, including the sales force expansion following ZUSDURI approval and higher brand marketing expenses, an increase in overall commercial operation costs, and higher advisory costs, including fees associated with the Pharmakon Advisors debt refinancing in the first quarter of 2026.
Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.5 million in the first quarter of 2026 compared with $4.6 million in the same period in 2025.
Interest Expense on Long-term Debt: Interest expense related to long-term debt was $4.2 million in the first quarter of 2026, compared to $4.1 million in the same period in 2025. The increase in interest expense was primarily attributable to the additional borrowings of $75.0 million in the first quarter of 2026 in connection with the Pharmakon refinancing of long-term debt, offset by the lower interest rate.
Net Loss: UroGen reported a net loss of $23.6 million or ($0.47) per basic and diluted share in the quarter ended March 31, 2026, compared with a net loss of $43.8 million or ($0.92) per basic and diluted share in the first quarter of 2025.
Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, cash, cash equivalents and marketable securities totaled $140.3 million.
2026 JELMYTO Revenue and Company Operating Expense Guidance: The Company continues to expect 2026 net product revenue for JELMYTO to be in the range of $97 million to $101 million. This implies a year-over-year growth rate of approximately 3% to 7% over the $94 million of JELMYTO revenue reported in 2025. The Company is not providing full-year 2026 revenue guidance for ZUSDURI at this time, as the product remains in the early stages of its commercial launch. The Company continues to expect full-year 2026 operating expenses to be in the range of $240 million to $250 million, including non-cash share-based compensation expense of $20 million to $24 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 http://investors.UroGen.com. 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.
UROGEN PHARMA LTD.
SELECTED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
March 31, 2026
December 31, 2025
Cash and cash equivalents and marketable securities
$
140,274
$
120,456
Total assets
