Key Highlights

• ZUSDURI generated $68.0 million in net product Revenue in Q3 2026, representing 35% quarter-over-quarter growth

• Total revenue reached $89.0 million, compared to $27.5 million in Q3 2025, a more than threefold increase

• FDA accepted NDA for UGN-103 with a PDUFA target action date of June 14, 2027

• First patient dosed in the Phase 1 trial of UGN-501, an investigational oncolytic virus for high-grade NMIBC

UroGen Pharma Ltd. (NASDAQ:URGN), a biotechnology company focused on developing treatments for urothelial and specialty cancers, has reported financial results for the third quarter ended September 30, 2026. The quarter was marked by accelerating commercial momentum for its bladder cancer therapy ZUSDURI, continued pipeline advancement, and a more than threefold increase in total revenue compared to the prior year.

ZUSDURI's Commercial Trajectory

ZUSDURI, the company's treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), generated $68.0 million in net product revenue during the quarter, representing a 35% increase from the second quarter of 2026. Key adoption metrics showed broadening utilization, with 1,538 activated sites of care as of September 30, 2026, up from 1,444 at the end of Q2. The number of unique ZUSDURI prescribers rose to 662 from 452, while repeat prescribers increased to 331 from 204, accounting for approximately 50% of total prescribers.

JELMYTO, UroGen's therapy for low-grade upper tract urothelial cancer, contributed $21.0 million in net product revenue for the quarter, compared to $25.7 million in Q3 2025. The decline reflected a one-time unfavorable gross-to-net adjustment of approximately $1.5 million related to a CMS invoice, as well as ongoing competitive clinical trial enrollment activity affecting patient starts.

Pipeline Advancement and FDA Developments

In October 2026, the FDA accepted UroGen's NDA for UGN-103, a next-generation mitomycin-based formulation, and assigned a PDUFA target action date of June 14, 2027. The NDA is based on clinical data from the Phase 3 UTOPIA trial. The three-month complete response rate, six-month duration of response, and safety results from UTOPIA were consistent with those observed in the pivotal ENVISION trial of ZUSDURI.

The company also announced that the first patient began treatment with UGN-501, an investigational oncolytic virus, in a Phase 1 trial evaluating its safety and tolerability for intravesical administration in high-grade NMIBC. UroGen plans to initiate the Phase 3 LONGVIEW-HR trial in Q4 2026, evaluating adjuvant UGN-103 versus intravesical gemcitabine in patients with recurrent high-risk NMIBC who previously received BCG therapy, with enrollment planned for approximately 300 patients.

Additionally, UroGen entered into a strategic collaboration with IntraGel Therapeutics in August 2026, providing an exclusive option to evaluate up to three future oncology products using IntraGel's biodegradable sustained-release depot technology.

Financial Results for Q3 2026

Total revenue was $89.0 million in Q3 2026, compared to $27.5 million in the same period last year, driven almost entirely by the continued commercial ramp of ZUSDURI.

Research and development expenses rose to $26.0 million from $14.0 million in Q3 2025, reflecting increased clinical development costs for UGN-103 and UGN-104, the PDUFA fee related to the UGN-103 NDA submission, and development costs for UGN-501. Selling, general and administrative expenses grew to $47.2 million from $37.6 million, driven by ZUSDURI commercial activities and expanded commercial operations.

The company reported non-cash financing expense of $4.5 million related to its prepaid forward obligation with RTW Investments, roughly in line with $4.6 million in the year-ago period.

Looking Ahead

UroGen enters the final stretch of 2026 with a growing ZUSDURI franchise, an FDA decision on UGN-103 expected by mid-2027, and early clinical work underway on its oncolytic virus platform. The company's new Patent covering LG-IR-NMIBC treatment, listed in the FDA's Orange Book and providing coverage into July 2044, adds a layer of commercial protection for its bladder cancer portfolio. With multiple clinical milestones ahead and accelerating revenue growth, the coming quarters will be closely watched.