Urogen Pharma Ltd is a biotechnology company focused on developing and commercializing innovative therapies for treating uro-oncological diseases. The company specializes in the research and development of novel drug formulations that target bladder cancer and other urological conditions, aiming to address significant unmet medical needs. With a commitment to advancing patient care, Urogen leverages its proprietary technology platforms to create transformative treatment options that enhance patient outcomes and improve the quality of life for individuals affected by these serious conditions. Read More
PRINCETON, N.J., May 15, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company focused on transforming the treatment of urothelial and specialty cancers, today announced UGN-103 achieved a 94.5% (95% CI: 86.1, 97.9) durability of response (DOR) at six months by Kaplan-Meier estimate, in the ongoing Phase 3 UTOPIA trial of UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR observed with ZUSDURI™ (mitomycin) for intravesical therapy in its pivotal ENVISION trial. ZUSDURI is the first and only treatment approved by the U.S. Food and Drug Administration (FDA) for adult patients with recurrent LG-IR-NMIBC.
PRINCETON, N.J., May 13, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% - 72.8%) by Kaplan-Meier estimate in patients who achieved a complete response (CR) at three months (79.6%) in the pivotal Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution. At a median follow-up of 35.5 months, the median DOR had not been reached. These data demonstrate that a substantial proportion of complete responders remained disease-free at three years, and durable outcomes were achieved without the need for maintenance therapy.
PRINCETON, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will participate in the following investor conferences in May.
PRINCETON, N.J., May 06, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2026, and provided an overview of recent developments.
PRINCETON, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the publication of results from the pivotal Phase 3 ENVISION trial of ZUSDURI™ (mitomycin) for intravesical solution in The Journal of Urology. ZUSDURI is indicated for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The publication reports a 72.2% probability of remaining event-free at 24 months after complete response (CR) (95% CI: 64%, 79%) as determined by Kaplan-Meier analysis. The CR rate at three months was 79.6%. The median follow-up time after three-month CR was 23.7 months, and the median DOR was not reached.
PRINCETON, N.J., March 13, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd., a biotechnology company dedicated to developing innovative therapies for urothelial and specialty cancers, today commended the Bladder Cancer Advocacy Network (BCAN) on its release of The New Faces of Bladder Cancer Report, a national patient-reported survey underscoring the chronic and recurrent nature of bladder cancer.
PRINCETON, N.J., March 06, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 11 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of JELMYTO® (mitomycin) for pyelocalyceal solution and ZUSDUR™ (mitomycin) for intravesical solution, UroGen’s only approved products, and the continued development of UroGen’s pipeline.
PRINCETON, N.J., March 02, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent developments.
• EORTC Recurrence Score Analysis from the Pivotal ENVISION Trial to be Presented at the 2026 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO-GU 2026)
PRINCETON, N.J., Feb. 24, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will present at the TD Cowen 46th Annual Health Care Conference to take place March 2-4, 2026.
PRINCETON, N.J., Feb. 04, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that management will present at the Guggenheim Securities Emerging Outlook: Biotech Summit to take place on February 11-12, 2026.
