UroGen Raises 2026 Operating-Expense Guidance After ZUSDURI Launch

The Tip Desk · August 5, 2026 · 4 min read

ZUSDURI net product revenue reached $50.4 million in the second quarter of 2026, and the company lifted full-year operating-expense guidance to $260 million to $270 million.

UroGen Pharma Ltd. (URGN), a biotech company developing treatments for urothelial and specialty cancers, reported ZUSDURI net product revenue of $50.4 million in the second quarter of 2026, up 73% from $29.2 million in the first quarter after 109% quarter-over-quarter growth in that prior period.

The increase in total revenue was driven by the continued commercial launch of ZUSDURI. Total revenue was $72.5 million in the three months ended June 30, 2026, compared with $24.2 million a year earlier. Operating income was $111 thousand, versus an operating loss of $41.4 million in the year-ago quarter.

President and Chief Executive Officer Liz Barrett said the quarter marked another step in establishing ZUSDURI as a foundational therapy for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, and that continued utilization, expanding adoption across community practices, and growing repeat use reinforced the company’s view that it is building a durable commercial franchise.

As of June 30, 2026, UroGen had 1,444 activated sites of care, up from 972 as of March 31. Unique ZUSDURI prescribers increased to 452 from 256. Repeat prescribers were 204, about 45% of total prescribers, up from 40% in the first quarter. Updated Phase 3 ENVISION results showed a 36-month duration of response of 64.5% among patients who achieved a complete response at three months.

JELMYTO generated net product revenue of $22.0 million in the quarter ended June 30, 2026, compared with $24.2 million in the second quarter of 2025. The company continues to add new users and remains on track for full-year 2026 JELMYTO net product revenue of $97 million to $101 million, implying about 3% to 7% growth over $94 million of 2025 JELMYTO revenue. It is not providing full-year 2026 revenue guidance for ZUSDURI, as the product remains in the early stages of its commercial launch.

UroGen entered a settlement and license agreement with Teva Pharmaceuticals that resolves patent litigation over a generic JELMYTO application. Under the agreement, UroGen granted Teva a non-exclusive license to sell a generic version beginning September 15, 2030, if approved by the FDA.

The company received a Notice of Allowance from the U.S. Patent and Trademark Office for a new U.S. patent covering methods of treating LG-IR-NMIBC without transurethral resection of bladder tumor. Once issued, the patent is expected to provide protection into July 2044 for both ZUSDURI and UGN-103.

Selling, general and administrative expenses were $48.4 million in the second quarter of 2026, up from $43.2 million a year earlier. The increase primarily reflected ZUSDURI commercial activities, including sales-force expansion after approval and higher brand marketing. Research and development expenses were $17.3 million, down from $18.9 million, primarily because ZUSDURI manufacturing costs were recognized as R&D in the second quarter of 2025 before FDA approval.

Net loss narrowed to $14.4 million, or $0.28 a share, from $49.9 million, or $1.05 a share, a year earlier. Cash, cash equivalents and marketable securities were $108.0 million as of June 30, 2026.

UroGen is increasing full-year 2026 operating-expense guidance to $260 million to $270 million, including $20 million to $24 million of non-cash share-based compensation. The increase reflects a decision to accelerate investment behind the business in response to the continued strength of the ZUSDURI launch, including more ZUSDURI peer-to-peer promotional education and patient-awareness initiatives, and faster start-up of the UGN-103 high-grade NMIBC trial and UGN-501 development.

UGN-103 NDA timing was narrowed to the third quarter of 2026, from a second-half 2026 target, with potential FDA approval in 2027. Six-month duration of response in the Phase 3 UTOPIA trial was 94.5%. The company expects to initiate a randomized Phase 3 trial of UGN-103 in high-risk NMIBC in the second half of 2026. The FDA accepted the investigational new drug application for UGN-501, and UroGen plans to start a Phase 1 trial in NMIBC in the fourth quarter of 2026.