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. (URGN) is a biotechnology company whose news flow centers on therapies for urothelial and specialty cancers. Company announcements highlight the development and commercialization of RTGel®-based mitomycin formulations and other oncology candidates designed for non-surgical tumor ablation in the urinary tract.
On this page, readers can follow news about Jelmyto for low-grade upper tract urothelial cancer and ZUSDURI™ (mitomycin) for intravesical solution, described by UroGen as the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Updates often cover regulatory milestones such as U.S. Food and Drug Administration approvals, the assignment of a permanent HCPCS Level II J Code (J9282) for ZUSDURI, and coverage or reimbursement developments that affect access to treatment.
UroGen’s disclosures also include clinical trial results and pipeline progress, including data from the Phase 3 UTOPIA trial of UGN-103 for recurrent LG-IR-NMIBC, the clinical development program for ZUSDURI across studies such as OPTIMA II, ATLAS, and ENVISION, and ongoing work on next-generation candidates UGN-104 and UGN-501. Investors and healthcare professionals can track conference presentations, financial result releases, and corporate updates, such as inducement equity grants and proxy-related matters.
By reviewing the URGN news feed on Stock Titan, users can monitor how UroGen’s RTGel platform, approved products, and late-stage pipeline evolve over time, and how regulatory, clinical, and commercial developments may influence the company’s oncology portfolio.
UroGen Pharma (Nasdaq: URGN), a biotechnology company focused on developing treatments for urothelial and specialty cancers, has announced its participation in the TD Cowen 6th Annual Oncology Innovation Summit. The company will engage in a fireside chat on May 28, 2025, at 9:00 AM ET. The event, which focuses on insights for ASCO & EHA, will be held virtually. A webcast of the presentation will be available on UroGen's Investor Relations website, with replay access for approximately 90 days.
UroGen (URGN) announced that the FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) meeting on May 21, 2025 to review the new drug application for UGN-102, a treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA's PDUFA target action date is set for June 13, 2025.
The drug's Phase 3 ENVISION trial showed impressive results with a 79.6% complete response rate at 3 months after first instillation, and 82.5% duration of response at 12 months. Notably, UGN-102 is being developed for a condition that currently has no FDA-approved drugs.
UroGen Pharma (Nasdaq: URGN), a biotech company focused on developing treatments for urothelial and specialty cancers, has scheduled its first quarter 2025 financial results announcement for Monday, May 12, 2025. The company will release its results before market open, followed by a live audio webcast and conference call at 10:00 AM ET. Investors can access the webcast through UroGen's Investor Relations website, with a replay available for approximately 30 days after the event.
UroGen Pharma (NASDAQ: URGN) has reported significant long-term follow-up data for JELMYTO®, its FDA-approved treatment for low-grade upper tract urothelial cancer (LG-UTUC). The study, presented at the 2025 American Urological Association Annual Meeting, showed a median duration of response of 47.8 months among patients who achieved complete response after primary chemoablation.
The analysis included 41 patients from the OLYMPUS trial, with 21 having new-onset UTUC and 20 with recurrent UTUC. Both groups showed similar durability, with 8 patients in each experiencing recurrence or death not due to treatment. Twenty patients entered long-term follow-up with a median follow-up of 53.3 months.
The company is currently conducting the uTRACT Registry (NCT05874921) to gather real-world usage data, with 22 sites activated and 251 patients enrolled as of April 2025.
Summary not available.
Summary not available.
UroGen Pharma (URGN) reported updated results from its Phase 3 ENVISION trial of UGN-102, showing an 18-month duration of response (DOR) of 80.6% in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The trial demonstrated that 79.6% of patients achieved complete response at three months.
The investigational treatment aims to provide an alternative to the current standard of care, which requires invasive surgical procedures (TURBT) under anesthesia. An estimated 59,000 patients with LG-IR-NMIBC face recurring surgeries annually. The FDA has accepted UroGen's New Drug Application for UGN-102 with a PDUFA date of June 13, 2025.
Common treatment-emergent adverse events were generally mild-to-moderate, including dysuria, hematuria, and urinary tract infection. The safety profile was consistent with previous UGN-102 studies.