Welcome to our dedicated page for Urogen Pharma news (Ticker: URGN), a resource for investors and traders seeking the latest updates and insights on Urogen Pharma stock.
UroGen Pharma Ltd. develops and commercializes therapies for urothelial and specialty cancers, with recurring updates centered on approved mitomycin products and its RTGel® reverse-thermal hydrogel platform. Company announcements commonly address JELMYTO for low-grade upper tract urothelial cancer and ZUSDURI for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, including product revenue, reimbursement coding, physician education and real-world treatment experience.
UroGen news also covers clinical data publications, pipeline programs such as UGN-103 and UGN-501, research and development spending, debt financing, employee equity inducement grants and investor-conference participation. The company’s updates connect commercial execution with sustained-release local therapy designed to increase urinary tract tissue exposure to medication.
UroGen (Nasdaq: URGN) reported second quarter 2026 revenue of $72.5 million, up from $24.2 million a year earlier, driven by ZUSDURI net product revenue of $50.4 million, representing 73% quarter-over-quarter growth. JELMYTO contributed $22.0 million, versus $24.2 million in Q2 2025.
UroGen recorded a net loss of $14.4 million ($0.28/share), significantly improved from a $49.9 million loss in Q2 2025, with slight operating income of $0.1 million. The company highlighted a new U.S. patent allowance expected to protect ZUSDURI and UGN-103 into July 2044, strong durability data from the Phase 3 ENVISION trial, progress of UGN-103 toward an NDA filing in Q3 2026 and a Phase 1 start for UGN-501 in Q4 2026. Guidance includes 2026 JELMYTO revenue of $97–$101 million and increased 2026 operating expenses of $260–$270 million. Cash, cash equivalents and marketable securities totaled $108.0 million at June 30, 2026.
UroGen Pharma (Nasdaq: URGN) will report its second quarter 2026 financial results on Wednesday, August 5, 2026, before the U.S. stock market opens. The company will host a live audio webcast and conference call at 10:00 AM Eastern Time, with access and a 30-day replay available via its Investor Relations website.
UroGen (Nasdaq: URGN) received a U.S. Patent and Trademark Office Notice of Allowance for patent application 18/784,354 covering methods of treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer without transurethral resection of a bladder tumor (TURBT).
The allowed claims are supported by ENVISION and ATLAS clinical trial data for ZUSDURI and the investigational candidate UGN-103, both using UroGen’s RTGel technology to deliver mitomycin as a primary, non-surgical treatment. The patent, once issued, is expected to provide U.S. protection into July 2044, which UroGen says strengthens its intellectual property position and supports long-term growth opportunities.
UroGen (Nasdaq: URGN) received FDA clearance of its Investigational New Drug (IND) application for UGN-501, an investigational next-generation oncolytic virus for non-muscle invasive bladder cancer (NMIBC).
The clearance enables a planned Phase 1 study of intravesical UGN-501, with patient enrollment expected to start in Q4 2026.
UroGen Pharma (Nasdaq: URGN) granted inducement restricted stock units (RSUs) to 21 new employees under Nasdaq Listing Rule 5635(c)(4). These hires will support commercialization of JELMYTO and ZUSDURI and pipeline development. Up to 102,700 ordinary shares are issuable as the RSUs vest equally over three years.
UroGen (Nasdaq: URGN) entered a settlement and license agreement with Teva, resolving patent litigation over Teva’s ANDA for a generic version of JELMYTO.
Teva receives a non-exclusive license to sell its generic starting September 15, 2030, if FDA approved. JELMYTO holds regulatory exclusivity through April 15, 2027 and Orange Book patents expiring January 20, 2031.
UroGen Pharma (Nasdaq: URGN) will present at the Goldman Sachs 47th Annual Global Healthcare Conference, held June 8–10, 2026.
Management is scheduled for a fireside chat and 1x1 investor meetings on June 10, 2026 at 8:40 AM ET in Miami Beach, FL, with a webcast and 90-day replay.
UroGen (Nasdaq: URGN) reported that UGN-103 achieved a 94.5% six-month durability of response (95% CI: 86.1, 97.9) in the ongoing Phase 3 UTOPIA trial for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The result is generally consistent with the 91.9% six-month DOR seen with FDA-approved ZUSDURI in ENVISION. UroGen plans to submit a New Drug Application for UGN-103 in Q3 2026 and highlights streamlined manufacturing, simplified reconstitution, and RTGel technology, with U.S. patents expected to protect UGN-103 into December 2041.
UroGen Pharma (Nasdaq: URGN) reported updated Phase 3 ENVISION results for ZUSDURI in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Among patients achieving complete response at three months (79.6%), Kaplan-Meier analysis showed a 64.5% 36-month duration of response; median DOR was not reached at 35.5 months’ follow-up and responses occurred without maintenance therapy.
UroGen Pharma (Nasdaq: URGN) announced participation in three investor conferences in May 2026: Bank of America Health Care Conference (May 13, 11:15 AM ET, Las Vegas), HC Wainwright BioConnect (May 19, 10:30 AM ET, New York), and TD Cowen Oncology Innovation Summit (May 26, 10:30 AM ET, virtual).
Webcasts will be available on UroGen’s Investor Relations website and replayed for approximately 90 days.