Urogen Pharma (NASDAQ:URGN) reported third-quarter revenue of $89 million, more than triple the $27.5 million recorded a year earlier, as sales of bladder cancer treatment ZUSDURI continued to grow. The company said it expects to achieve profitability and generate positive cash flow in the fourth quarter of 2026.
ZUSDURI generated $68 million in net product revenue, up 35% from the second quarter. JELMYTO, the company’s treatment for low-grade upper tract urothelial cancer, contributed $21 million, down from $22 million in the preceding quarter.
UroGen narrowed its quarterly net loss to $1.5 million, or $0.03 per share, from $33.3 million, or $0.69 per share, in the third quarter of 2025. The company ended September with $90.5 million in cash, cash equivalents and marketable securities, along with $117 million in accounts receivable.
ZUSDURI Adoption Continues to Expand
President and CEO Liz Barrett said UroGen had more than 1,500 activated accounts as of Sept. 30. The number of unique ZUSDURI prescribers rose to 662 from 452 in the second quarter, while repeat prescribers increased to 331 from 204.
Repeat prescribers represented 50% of total writers, up from 45% in the second quarter and 40% in the first. Barrett said community practices accounted for most utilization, an important market for the company because approximately 70% of its addressable patients are in that setting.
ZUSDURI is approved for adults with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer. Chief Medical Officer Mark Schoenberg said the treatment provides a surgery-free primary therapy with a six-week course and no maintenance treatment.
Barrett said anecdotal information and the company’s claims database suggest that more than 60% of use is as a primary treatment, with less than 40% used after surgery. She cautioned that the company does not capture a definitive quantitative split.
UroGen observed some seasonal slowing in new patient enrollment during the summer, but Barrett said it appeared to have had minimal revenue impact. The company expects sequential ZUSDURI revenue growth in the fourth quarter, while noting that holidays could slow patient starts and shipments.
Chief Financial Officer Chris Degnan said the company was not issuing full-year ZUSDURI guidance while the launch remains in its early stages. He said the product’s recent quarterly increases of roughly $15 million to $20 million were a reasonable framework for a steady growth trajectory, though results could vary from quarter to quarter.
Barrett said a direct-to-consumer campaign planned for around mid-2027 and wider adoption protocols at large community practices could eventually accelerate growth. She said she did not expect an inflection point in the next few quarters.
JELMYTO Guidance Updated
UroGen updated its full-year JELMYTO net product revenue guidance to approximately $90 million. The third-quarter result included a one-time unfavorable gross-to-net adjustment of approximately $1.5 million related to a Centers for Medicare and Medicaid Services discarded-drug provision true-up.
Barrett said clinical trials competing for patients, including UroGen’s own UGN-104 study, have also affected JELMYTO patient starts. She expects clinical-trial competition to remain a headwind in 2027, but said the company is developing a team to increase promotional focus on the product’s heavy users.
Schoenberg highlighted published five-year follow-up results from the phase III OLYMPUS trial. Among 41 patients who achieved a complete response, median duration of response was 47.8 months. Of 20 patients who entered long-term follow-up, 75% remained event-free at their last assessment, with a median follow-up of 53.3 months.
UGN-103 Review and Pipeline Plans
The FDA accepted UroGen’s application for UGN-103, its next-generation investigational therapy for recurrent low-grade intermediate-risk bladder cancer, and set a decision goal date of June 14, 2027. Schoenberg said the company plans to supplement the application with 12-month duration-of-response data when available.
If approved, UroGen intends to seek a permanent reimbursement J-code by the July 1, 2027 submission deadline, with a potential effective date of Jan. 1, 2028. Degnan said the company plans to introduce UGN-103 in the first half of 2028 and expects both it and ZUSDURI to remain available for several months during the transition. UroGen plans to withdraw ZUSDURI once most patients have moved to the newer product.
UroGen also plans to start a randomized phase III trial of UGN-103 in high-risk non-muscle-invasive bladder cancer in the fourth quarter of 2026. Separately, the company expects to complete enrollment in its phase III UGN-104 trial by year-end or early 2027. Its first patient has been dosed in a phase I trial of UGN-501, with initial data anticipated in 2027.
Spending and Profitability Outlook
Third-quarter research and development expenses rose to $26 million from $14 million a year earlier, while selling, general and administrative expenses increased to $47.2 million from $37.6 million. Degnan attributed the increases to clinical development costs and spending on the ZUSDURI launch.
UroGen maintained its 2026 operating expense guidance of $260 million to $270 million, including $20 million to $24 million in non-cash share-based compensation, but said expenses would likely be toward the upper end of the range. Degnan said the company remains confident it can fund operations through profitability with its existing resources.
About Urogen Pharma (NASDAQ:URGN)
UroGen Pharma Ltd. (NASDAQ: URGN) is a biopharmaceutical company focused on developing and commercializing treatments for cancers of the urinary tract. The company’s therapies are designed to deliver medicines directly to the affected area, with the goal of improving drug exposure while limiting systemic side effects.
UroGen’s primary commercial product is Jelmyto, a mitomycin-based treatment approved in the United States for adults with low-grade upper tract urothelial cancer. Jelmyto uses UroGen’s proprietary RTGel technology, which forms a gel in the urinary tract and enables the sustained local release of mitomycin.
The company has also developed UGN-102, an investigational mitomycin-based reverse thermal gel intended for the treatment of low-grade, intermediate-risk non-muscle-invasive bladder cancer.
