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 Pharma (URGN) reported third-quarter 2026 ZUSDURI revenue of $68.0 million, helping narrow its quarterly net loss. ZUSDURI sales grew 35% quarter over quarter. Total revenue reached $89.0 million versus $27.5 million a year earlier, while net loss narrowed to $1.5 million, or $0.03 per share, from $33.3 million, or $0.69 per share.
JELMYTO revenue fell to $21.0 million from $25.7 million. UroGen cut its 2026 JELMYTO revenue outlook to approximately $90 million from $97 million–$101 million and maintained operating expense guidance of $260 million–$270 million, anticipating the upper end. Cash, cash equivalents and marketable securities totaled $90.5 million at September 30.
The FDA accepted the UGN-103 drug application for review, with a June 14, 2027 target action date. UroGen also began treating the first patient in its UGN-501 Phase 1 trial and plans further UGN-103 trials.
UroGen Pharma (URGN) will present at the Guggenheim Securities 3rd Annual Healthcare Innovation Conference on November 10, 2026.
The presentation is scheduled for 11:30 AM ET in Boston, with a fireside chat and 1x1 investor meetings. A webcast will be available through the company's website under Events & Presentations, with a replay available for approximately 90 days.
UroGen Pharma (URGN) has dosed the first patient in its Phase 1 trial of UGN-501 for recurrent non-muscle invasive bladder cancer.
The trial evaluates administration directly into the bladder, focusing on safety, tolerability and pharmacokinetics, or how the treatment behaves in the body, and determining a recommended Phase 2 dose. The open-label, dose-escalation study includes adults with high-grade Ta/T1 disease and/or carcinoma in situ, or low-grade Ta/T1 disease. All visible papillary tumors must be removed and obvious carcinoma in situ areas destroyed before treatment. UroGen is also conducting nonclinical studies exploring UGN-501 formulated with its RTGel technology.
UroGen Pharma (Nasdaq: URGN) announced publication of final Olympus five-year follow-up results evaluating JELMYTO response durability in adults with low-grade upper tract urothelial cancer.
Among 41 patients who achieved a complete response after initial treatment, median response duration was 47.8 months, with median follow-up of 28.1 months (95% confidence interval: 13.1–60.1). Twenty patients entered long-term follow-up, with median follow-up of 53.3 months (95% confidence interval: 27.9–72.8). In that group, median response duration could not be estimated because too few events occurred; its 95% confidence interval was 43.5 months to not estimable. As of March 2025, 75% (15/20) remained event-free, with no progression to high-grade disease observed. The results appeared in Therapeutic Advances in Urology.
UroGen Pharma (URGN) will report third quarter 2026 financial results on November 4, 2026, before the stock market opens.
A conference call and live audio webcast will follow at 10:00 AM Eastern Time. The public webcast will be available on UroGen’s Investor Relations website, with a replay available for approximately 30 days.
UroGen Pharma (Nasdaq: URGN) announced FDA acceptance of its UGN-103 application for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The FDA assigned a June 14, 2027 target action date.
The application is supported by the ongoing Phase 3 UTOPIA trial, a single-arm study involving 99 patients. UGN-103 produced a 77.8% complete response rate at three months. Among those responders, the estimated probability of remaining event-free at six months was 94.5%. UroGen said response, response duration and safety results were consistent with those in ZUSDURI’s pivotal ENVISION trial.
UGN-103 combines UroGen’s sustained-release gel technology with medac’s licensed mitomycin formulation. UroGen holds U.S. patents covering the combination and its use in this bladder cancer, with coverage expected to extend into July 2044.
UroGen Pharma (URGN) granted inducement restricted stock units (RSUs) to 19 new employees on September 4, 2026, under Nasdaq Listing Rule 5635(c)(4).
Up to 117,100 ordinary shares are issuable upon vesting, which occurs in three equal annual installments over three years, subject to continued service and the company’s 2019 Inducement Plan.
UroGen Pharma (URGN) will participate in three investor conferences in September 2026, featuring fireside chats at healthcare-focused events hosted by Wells Fargo, Cantor, and H.C. Wainwright.
The sessions occur on September 9 at 3:00 PM ET in Boston, September 10 at 2:10 PM ET in New York, and September 15 at 9:00 AM ET in New York. Live webcasts and 30-day replays will be accessible via UroGen’s investor relations website.
IntraGel Therapeutics announced a strategic collaboration with UroGen Pharma (Nasdaq: URGN), combining an equity investment of up to $7 million with an Option and Research License Agreement. The investment is intended to support IntraGel’s Phase 2 clinical study of TumoCure, an investigational SRGel‑based cisplatin therapy for advanced head and neck cancer.
Under the Option Agreement, UroGen receives an exclusive option to obtain an exclusive, worldwide license to develop and commercialize TumoCure after completion of Phase 2. UroGen also gains research access to IntraGel’s SRGel biodegradable sustained‑release platform and options for exclusive worldwide licenses to develop and commercialize up to three additional oncology products using SRGel with compounds designated by UroGen.
UroGen (Nasdaq: URGN) announced an Option and Research License Agreement and a related equity Investment Agreement with IntraGel Therapeutics to access its proprietary SRGel biodegradable sustained-release platform and expand UroGen’s oncology pipeline.
The Option Agreement grants UroGen a research license and exclusive options to obtain worldwide licenses to develop and commercialize up to three additional oncology products that combine SRGel with compounds designated by UroGen. UroGen also receives an exclusive option to secure worldwide rights to develop and commercialize TumoCure, IntraGel’s investigational therapy for advanced head and neck cancer, following completion of IntraGel’s Phase 2 study. According to UroGen, it will invest up to $7 million in IntraGel equity under the Investment Agreement. Early Phase 1b data for TumoCure (N=8), presented at ASCO 2026, showed the product was generally well tolerated, with low systemic cisplatin exposure, early signs of anti-tumor activity, and improvements in tumor-related symptoms in some heavily pretreated patients.