UroGen Pharma Ltd.

UroGen Pharma Ltd. reported a significant increase in revenue and a substantial reduction in net loss for the second quarter of 2026. Revenue rose to $72.46 million, up from $24.22 million in the prior year, while net loss improved to $(14.35) million from $(49.94) million. The company achieved positive operating income for the quarter. Despite these operational improvements, total liabilities and the accumulated deficit increased, and long-term debt grew to $188.73 million.

UroGen Pharma reported strong second-quarter 2026 financial results, with total revenue reaching $72.5 million, significantly up from $24.2 million in Q2 2025. This growth was primarily driven by ZUSDURI, which generated $50.4 million in revenue, marking a 73% quarter-over-quarter increase. The company also announced a new U.S. patent allowance expected to protect ZUSDURI and UGN-103 until July 2044, enhancing long-term intellectual property. Additionally, UroGen is on track to submit an NDA for UGN-103 in Q3 2026 and initiate a Phase 1 trial for UGN-501 in Q4 2026, while increasing its full-year operating expense guidance.

UroGen Pharma Ltd. announced it will report its second quarter 2026 financial results on Wednesday, August 5, 2026, before the stock market opens. This will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time. A replay of the webcast will be available on the company's Investor Relations website for about 30 days.

UroGen Pharma Ltd. shareholders approved several key proposals at the 2026 Annual Meeting. This included an amendment to the 2017 Equity Incentive Plan, increasing authorized shares by 1,000,000, and an amendment to the Articles of Association to align shareholder proposals with Israeli law. Additionally, shareholders approved an amendment to the Non-Employee Director and Officer Compensation Policy, elected seven directors, and re-appointed PricewaterhouseCoopers LLP as the independent auditor. An advisory vote on executive compensation also passed.

UroGen Pharma Ltd. announced a settlement and license agreement with Teva Pharmaceuticals, Inc., resolving patent litigation related to Jelmyto® (mitomycin) for pyelocalyceal solution. Under the terms, UroGen will grant Teva a non-exclusive license to sell its generic version of Jelmyto, with sales commencing on September 15, 2030, if approved by the FDA. This agreement will lead to the termination of all ongoing patent litigation between the companies.

UroGen Pharma Ltd. announced that its management will present at the Goldman Sachs 47th Annual Global Healthcare Conference. The presentation is scheduled for June 10, 2026, at 8:40 AM ET, and will feature a fireside chat along with 1x1 investor meetings in Miami Beach, FL. A webcast of the conference will be accessible on UroGen’s corporate website, with a replay available for approximately 90 days.

UroGen Pharma announced that UGN-103 achieved a 94.5% durability of response at six months in its Phase 3 UTOPIA trial for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). These results are consistent with the 91.9% six-month durability observed with ZUSDURI, the company's FDA-approved treatment. Based on these findings and FDA alignment, UroGen plans to submit a New Drug Application for UGN-103 in the third quarter of 2026, aiming to expand its uro-oncology portfolio.

UroGen Pharma announced positive 36-month duration of response (DOR) data from the pivotal Phase 3 ENVISION trial of ZUSDURI for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The data showed a 64.5% probability of remaining event-free at three years in patients who achieved a complete response (CR) at three months (79.6%). This durability was achieved without maintenance therapy, offering a non-surgical, in-office treatment that can reduce the burden of repeated TURBT procedures for patients.

UroGen Pharma reported strong financial results for Q1 2026, with revenue more than doubling to $51.0 million, a 151.6% increase year-over-year. The company significantly reduced its net loss by 46.2% to $(23.6) million, improving net loss per share to $(0.47). While net cash used in operating activities increased, UroGen Pharma secured $65.3 million in proceeds from long-term debt, contributing to a healthy cash position of $111.3 million at period end.

UroGen Pharma reported strong first-quarter 2026 financial results, with ZUSDURI™ revenue more than doubling quarter-over-quarter to $29.2 million, driven by broader utilization following the permanent J Code. Total revenue increased by 152% year-over-year to $51.0 million, while the net loss significantly narrowed to $23.6 million. The company also highlighted continued advancement of its pipeline, including UGN-103 on track for NDA submission and UGN-501 IND submission, and expanded its debt facility by $200 million.