UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) PRINCETON, N.J., Dec. 05, 2025 (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 14 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 ZUSDURI™ (mitomycin) for intravesical s...
UroGen Pharma to Present at the Piper Sandler 37th Annual Healthcare Conference PRINCETON, N.J., Nov. 25, 2025 (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 present at the Piper Sandler 37th Annual Healthcare Conference to take place on December 2-4, 2025. Piper Sandler 37th Annual Healthcare Conference Date / Time:December 2, 2025, at 1:00 PM ETFormat:Fireside ChatLocation:New York, NYWebcast Link: Webcasts from the confe...
UroGen Reports Third Quarter 2025 Financial Results as ZUSDURI™ Launch Gains Momentum Reported three-month complete response rate of 77.8% from the Phase 3 UTOPIA trial of UGN-103, consistent with ENVISION results; FDA agreed to regulatory plan to submit an NDA based on data from the UTOPIA trial ZUSDURI received unique J-Code (J9282) in October 2025, effective January 1, 2026ZUSDURI achieved net product revenue of $1.8 million in Q3 2025; October 2025 preliminary demand revenue estimate of $4.5 million reflecting accelerating growth entering Q4 2025JELMYTO® achieved net product revenue of ...
UroGen Reports 77.8% Three-Month Complete Response Rate from Phase 3 UTOPIA Trial of UGN-103 and Receives FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Based on UTOPIA Trial PRINCETON, N.J., Nov. 06, 2025 (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 robust preliminary results from its ongoing Phase 3 UTOPIA trial, demonstrating a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%) with UGN-103 (mitomy...
UroGen Pharma to Present at Guggenheim Securities Healthcare Innovation Conference PRINCETON, N.J., Nov. 04, 2025 (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 present at the Guggenheim Securities Healthcare Innovation Conference to take place on November 10-12, 2025. Guggenheim Securities Innovation Conference Date / Time:November 11, 2025 at 10:30 AM ETFormat:Presentation and 1x1 investor meetingsLocation:Boston, MAWebcast...
UroGen Pharma to Report Third Quarter 2025 Financial Results on Thursday, November 6th, 2025 Conference Call and Webcast Scheduled for Thursday, November 6th, 2025, at 10:00 AM ET PRINCETON, N.J., Oct. 30, 2025 (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 report third quarter 2025 financial results on Thursday, November 6th, 2025, prior to the open of the stock market. The announcement will be followed by a live audio webc...
Centers for Medicare and Medicaid Services Assigns Permanent J Code for ZUSDURI™ Effective January 1, 2026 PRINCETON, N.J., Oct. 27, 2025 (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 the Centers for Medicare and Medicaid Services (CMS) has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code, J9282, for ZUSDURI (mitomycin) for intravesical solution, the first and only FDA-approved medicine for adult...
ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent Low-Grade, Intermediate-Risk Non–Muscle Invasive Bladder Cancer PRINCETON, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company focused on developing and commercializing innovative solutions for urothelial and specialty cancers, today announced the publication of a comprehensive review of the clinical development program for ZUSDURI™ (mitomycin) for intravesical solution, formerly known as UGN-102, the first and only FDA-a...
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) PRINCETON, N.J., Sept. 08, 2025 (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 40 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 ZUSDURI™ (mitomycin) for intravesical ...
UroGen Pharma to Present at Upcoming Investor Conferences PRINCETON, N.J., Aug. 21, 2025 (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 September. Wells Fargo Healthcare Conference Date / Time:September 3rd, at 2:15 PM ETFormat:Fireside ChatLocation:Boston, MA Cantor Fitzgerald Global Healthcare Conference Date / Time:September 4th, at 3:55 PM ETFormat:Fireside ChatLocati...
UroGen Pharma Expands Commercial Portfolio with Launch of ZUSDURI™ and Reports Second Quarter 2025 Financial Results ZUSDURI™ (mitomycin) for intravesical solution now available as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)JELMYTO® achieved net product sales of $24.2 million in Q2 2025, compared with $21.8 million in Q2 2024, representing 11% year-over-year growth$161.6 million in cash, cash equivalents and marketable securities as of June 30, 2025 Conference call and webcast to be held to...
UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer 24-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) PRINCETON, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cance...
UroGen Pharma to Report Second Quarter 2025 Financial Results on Thursday, August 7th, 2025 Conference Call and Webcast Scheduled for Thursday, August 7th, 2025, at 10:00 AM ET PRINCETON, N.J., July 29, 2025 (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 report second quarter 2025 financial results on Thursday, August 7th, 2025, prior to the open of the stock market. The announcement will be followed by a live audio webcast a...
UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology PRINCETON, N.J., July 28, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative treatments for urothelial and specialty cancers, today announced the publication in Reviews in Urology of results from a Phase 3b study evaluating the feasibility of administering ZUSDURI™ (mitomycin) for intravesical s...
UroGen Announces Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI™ in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer Findings published in the journal of Clinical Genitourinary Cancer show patients remained event-free for a median of two years after achieving complete response with ZUSDURI (mitomycin) intravesical solution. Among the 17 patients who achieved complete response and entered a long-term extension study, the median duration of response was 3.5 years by Kaplan-Meier estimate. PRINCET...
UroGen Announces Completion of Enrollment in the Phase 3 UTOPIA Clinical Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer PRINCETON, N.J., July 07, 2025 (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 has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the ...
UroGen Pharma Announces Commencement of Public Offering of Ordinary Shares and Pre-Funded Warrants PRINCETON, N.J., June 17, 2024 (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 has commenced an underwritten public offering, subject to market and other conditions, to issue and sell its ordinary shares and pre-funded warrants. In connection with the proposed offering, UroGen also expects to grant the underwriters a 30-day option to p...
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