UroGen Narrows Loss as ZUSDURI Sales Reach $68 Million

The Tip Desk · November 11, 2026 · 5 min read

The biotech posted $89.0 million of third-quarter revenue and cut its net loss to $1.5 million, or $0.03 a share, as ZUSDURI commercialization continued.

UroGen Pharma Ltd. (URGN) reported total revenue of $89.0 million in the third quarter of 2026, compared with $27.5 million a year earlier, as the commercial launch of ZUSDURI continued to lift the company’s top line.

The Princeton, New Jersey biotechnology company, which develops treatments for urothelial and specialty cancers, said the increase was driven by ZUSDURI. Net product revenue for ZUSDURI (mitomycin) for intravesical solution was $68.0 million, up 35% from $50.4 million in the second quarter, after 73% sequential growth in the second quarter from $29.2 million in the first quarter.

Operating results flipped to operating income of $8.3 million from an operating loss of $27.4 million in the third quarter of 2025. The net loss narrowed to $1.5 million, or $0.03 a share, from $33.3 million, or $0.69 a share, a year earlier.

President and Chief Executive Officer Liz Barrett said the company delivered another strong quarter of execution, with ZUSDURI continuing to scale as growing repeat utilization, expanding community adoption, and broader physician engagement reinforced confidence in the long-term commercial opportunity.

As of September 30, 2026, UroGen reported 1,538 activated sites of care, compared with 1,444 as of June 30, 2026. Unique ZUSDURI prescribers increased to 662 from 452. Repeat prescribers rose to 331, about 50% of total prescribers, from 204, or about 45%. The company said those trends reflected continued growth in both the breadth and depth of ZUSDURI adoption.

JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer generated net product revenue of $21.0 million, compared with $25.7 million in the third quarter of 2025. Third-quarter results included a one-time unfavorable gross-to-net adjustment of approximately $1.5 million related to a Centers for Medicare and Medicaid Services invoice for the discarded drug program that included a prior-year true-up. Results also reflected ongoing competitive clinical trial enrollment activity affecting JELMYTO patient starts in LG-UTUC.

UroGen is updating its full-year 2026 net product revenue guidance for JELMYTO to approximately $90 million, compared with its prior range of $97 million to $101 million. The company said the revised outlook reflects the one-time CMS discard-drug true-up and competitive clinical-trial enrollment in the United States that has affected patient starts in LG-UTUC.

Research and development expenses were $26.0 million, including $0.9 million of non-cash share-based compensation, compared with $14.0 million a year earlier. The company attributed the increase primarily to UGN-103 and UGN-104 clinical development costs, the PDUFA fee related to the UGN-103 NDA submission, and increased development costs related to UGN-501. Selling, general and administrative expenses were $47.2 million, including $5.3 million of share-based compensation, compared with $37.6 million a year earlier, which the company attributed to ZUSDURI commercial activities and higher commercial operations costs.

Interest expense on long-term debt was $4.8 million, compared with $3.4 million a year earlier, after $75.0 million of first-quarter 2026 Pharmakon refinancing borrowings offset by a lower interest rate. Cash, cash equivalents and marketable securities totaled $90.5 million as of September 30, 2026, down from $120.5 million at December 31, 2025.

In October 2026, the FDA accepted UroGen’s NDA for UGN-103 in low-grade intermediate-risk non-muscle invasive bladder cancer and assigned a PDUFA target action date of June 14, 2027. The NDA is based on the Phase 3 UTOPIA trial. The company said three-month complete response, six-month duration of response, and safety results in UTOPIA were consistent with those in the pivotal ENVISION trial of ZUSDURI, and that it plans to submit 12-month duration-of-response data during the NDA review.

A new U.S. method-of-treatment patent covering non-surgical treatment of recurrent LG-IR-NMIBC was issued and listed in the Orange Book for ZUSDURI, with expected coverage into July 2044 for ZUSDURI and, if approved, UGN-103.

UroGen plans to initiate the Phase 3 LONGVIEW-HR trial in the fourth quarter of 2026 evaluating adjuvant UGN-103 versus intravesical gemcitabine in recurrent, papillary-only high-risk NMIBC patients who previously received BCG therapy, with enrollment planned for approximately 300 patients. The company also plans a non-registrational trial in 2027 of UGN-103 as adjuvant therapy in newly diagnosed intermediate-risk NMIBC. Enrollment in the ongoing Phase 3 trial of UGN-104 in LG-UTUC is expected to complete by the end of 2026 or in early 2027.

The FDA cleared UroGen’s IND for UGN-501 in July 2026. In November 2026, the company announced that the first patient began treatment in the Phase 1 trial intended to evaluate safety, tolerability, and feasibility of intravesical administration.

In August 2026, UroGen entered a strategic collaboration with IntraGel Therapeutics providing an exclusive option to evaluate and develop up to three future oncology products using IntraGel’s SRGel platform and an exclusive option to acquire worldwide rights to IntraGel’s Phase 2-ready investigational cisplatin therapy for locally advanced, inoperable head and neck cancer. UroGen agreed to invest up to $7 million in IntraGel equity, of which $4 million was invested in the third quarter.

The company continues to expect full-year 2026 operating expenses in the range of $260 million to $270 million, with expenses anticipated toward the upper end of the range, including non-cash share-based compensation of $20 million to $24 million.