UroGen Pharma

URGN

Market cap $1.14B

UroGen Pharma (URGN) is rated a Strong Buy, with a $33/share price target by end of 2026, driven by its proprietary RTGel technology. URGN's newly approved Zusduri targets a large bladder cancer market, offering a non-surgical alternative, with strong clinical results and significant revenue potential. Jelmyto's commercial success in a smaller market supports confidence in Zusduri's launch, with analysts projecting URGN to reach profitability by 2027.

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.

UroGen Pharma Ltd. ( URGN ) Q3 2025 Earnings Call November 6, 2025 10:00 AM EST Company Participants Vincent Perrone - Senior Director of Investor Relations Elizabeth Barrett - President, CEO & Director Mark Schoenberg - Chief Medical Officer David Lin - Chief Commercial Officer Christopher Degnan - Chief Financial Officer Conference Call Participants Tara Bancroft - TD Cowen, Research Division Paul Jeng - Guggenheim Securities, LLC, Research Division Kelsey Goodwin - Piper Sandler & Co., Research Division Raghuram Selvaraju - H.C.

Urogen Pharma (URGN) came out with a quarterly loss of $0.69 per share versus the Zacks Consensus Estimate of a loss of $0.72. This compares to a loss of $0.55 per share a year ago.

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, 2026 ZUSDURI 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 2025 JELMYTO® achieved net product revenue of $25.7 million in Q3 2025, representing YoY underlying demand revenue growth of 13% $127.4 million in cash, cash equivalents and marketable securities as of September 30, 2025 Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

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 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This result is consistent with the 79.6% three-month CR rate (95% CI, 73.9%, 84.5%) observed following treatment with ZUSDURI in the pivotal ENVISION trial. In addition, the U.S. Food and Drug Administration (FDA) agreed that CR and durability results from the UTOPIA trial can support the submission of a New Drug Application (NDA) for UGN-103 for recurrent LG-IR-NMIBC.

PRINCETON, N.J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd.

UroGen Pharma is revisited after a previous Strong Buy rating, with UroGen having increased ~95% since then. The article reflects on UroGen's RTGel technology, which supports JELMYTO and ZUSDURI, its two FDA-approved products. JELMYTO has grown its revenues, but they are starting to taper off.

Conference Call and Webcast Scheduled for Thursday, November 6th, 2025, at 10:00 AM ET Conference Call and Webcast Scheduled for Thursday, November 6th, 2025, at 10:00 AM ET

Urogen Pharma (URGN) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.