reports
Journal of Urology Publishes ENVISION Trial Results Showing 72.2% 24-M...
Journal of Urology Publishes ENVISION Trial Results Showing 72.2% 24-Month Duration of Response with ZUSDURI 72.2% Probability of Remaining Event-Free at 24 Months by Kaplan-Meier Analysis After Achieving Complete Response at Three Months (79.6%) 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...
UroGen Applauds BCAN’s New Faces of Bladder Cancer Report Highlighting...
UroGen Applauds BCAN’s New Faces of Bladder Cancer Report Highlighting Recurrence Burden and Fear of Recurrence National survey of more than 1,100 bladder cancer patients finds nearly 80% report fear of recurrence, rising above 90% among patients under 50Many respondents report undergoing five or more cystoscopies, with some experiencing more than 15 procedures 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...
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 56...
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) 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 s...
UroGen Announces ZUSDURI™ Launch is On-Track and Reports Fourth Quarte...
UroGen Announces ZUSDURI™ Launch is On-Track and Reports Fourth Quarter and Full Year 2025 Financial Results Commercial launch is on-track for ZUSDURI™, the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC); net sales in 2025 were $15.8 million, reflecting the initial launch period ahead of the permanent J CodePermanent J Code for ZUSDURI became effective on January 1, 2026, streamlining reimbursement procedures and supporting broader patient accessJELMYTO® achieved net product sales of $94 million i...
UroGen Announces Refinanced Term Loan Agreement with Pharmakon Advisor...
UroGen Announces Refinanced Term Loan Agreement with Pharmakon Advisors Opportunistic refinancing meaningfully reduces cost of capital with 8.25% fixed interest rate and extends amortization period to Q1 2030 $200 million funded at closing to refinance the existing $125 million debt facility and provide additional non-dilutive capital Additional $50 million tranche available at Company’s discretion until June 30, 2027 PRINCETON, N.J., March 02, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that ...
ZUSDURI™ Achieves Durable Complete Responses Across EORTC Risk Groups ...
ZUSDURI™ Achieves Durable Complete Responses Across EORTC Risk Groups in Patients with Recurrent LG-IR-NMIBC • 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. 27, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative, non-surgical therapies for urothelial and specialty cancers, today announced new post-hoc analyses from the Phase 3 ENVISION trial showing that ...
UroGen Pharma to Present at the TD Cowen 46th Annual Health Care Confe...
UroGen Pharma to Present at the TD Cowen 46th Annual Health Care Conference 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. TD Cowen 46th Annual Health Care Conference Date / Time:March 3, 2026, at 1:50 PM ETFormat:Presentation and 1x1 investor meetingsLocation:Boston, MAWebcast Link: The webcast fro...
UroGen Pharma to Report Fourth Quarter and Full-Year 2025 Financial Re...
UroGen Pharma to Report Fourth Quarter and Full-Year 2025 Financial Results on Monday, March 2, 2026 Conference Call and Webcast Scheduled for Monday, March 2, 2026 at 10:00 AM ET PRINCETON, N.J., Feb. 23, 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 report fourth quarter and full-year 2025 financial results on Monday, March 2nd , 2026, prior to the open of the stock market. The announcement will be followed by a live...
UroGen Pharma to Present at the Guggenheim Securities Emerging Outlook...
UroGen Pharma to Present at the Guggenheim Securities Emerging Outlook: Biotech Summit 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. Guggenheim Emerging Outlook: Biotech Summit 2026 Date / Time:February 12, 2026, at 2:30 PM ETFormat:Fireside Chat and 1x1 investor meetingsLocation...
Permanent J Code for ZUSDURI™ Now in Effect, Expanding Patient Access ...
Permanent J Code for ZUSDURI™ Now in Effect, Expanding Patient Access to Innovative Bladder Cancer Therapy PRINCETON, N.J., Jan. 05, 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 adult patients living with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC) now have improved access to an important therapy, as the permanent Healthcare Common Procedure Coding System Level II J Code for ZUSDURI™ (...
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 56...
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 C...
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...
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 U...
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 Innovatio...
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 Thursd...
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 fo...
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 D...
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 56...
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
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...
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