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.
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UroGen Pharma Ltd. (Nasdaq: URGN) will participate in a fireside chat at the H.C. Wainwright BioConnect Conference on
A live audio webcast will be accessible via the company's investor website, with a replay available for approximately 30 days post-event.
UroGen specializes in proprietary technologies, notably RTGel®, a sustained-release hydrogel platform that enhances drug efficacy in treating urinary tract conditions. Its products, including Jelmyto® and investigational UGN-102, aim to non-surgically ablate tumors. UroGen is based in
UroGen Pharma Ltd. reported full-year 2022 net product revenues of $64.4 million, a 34% increase from 2021. The company completed patient enrollment in the ENVISION Phase 3 trial for UGN-102 targeting low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Topline data from pivotal studies is expected mid-2023, with an NDA submission anticipated in 2024. UroGen aims for 2023 JELMYTO revenues between $76 million and $86 million. However, the company reported a net loss of $109.2 million for 2022. As of year-end, cash and equivalents totaled approximately $100 million.
UroGen Pharma Ltd. (NASDAQ: URGN) will report its fourth quarter and full-year 2022 financial results on March 16, 2023, before the stock market opens. A conference call will follow at 10:00 AM ET, accessible via a live webcast on UroGen’s Investor Relations website. The company is focused on innovative treatments for urothelial and specialty cancers, featuring its proprietary RTGel™ hydrogel technology and products like Jelmyto® for non-surgical tumor ablation. UroGen aims to improve therapeutic options for patients through sustained release mechanisms.
UroGen Pharma Ltd. (Nasdaq: URGN) recently granted inducement restricted stock units (RSUs) to 7 new employees from March 1 to March 6, 2023, aimed at bolstering its workforce for the commercial launch of Jelmyto® and ongoing pipeline development. A total of 11,700 shares of common stock will be issued upon RSU vesting over three years, contingent on continued employment. The RSUs align with UroGen’s 2019 Inducement Plan and Nasdaq listing Rule 5635(c)(4). UroGen focuses on innovative treatments for urothelial and specialty cancers, with its first commercial product being Jelmyto®.
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech firm focused on innovative urothelial cancer treatments, is set to present at two investor conferences in March 2023. The Cowen 43rd Annual Health Care Conference will feature a panel presentation on March 7 from 12:50-1:50pm ET. The Oppenheimer 33rd Annual Healthcare Conference will include a presentation on March 14 from 10:40-11:10am ET. Webcasts for both events will be accessible on UroGen's website, with replays available for 30 days. UroGen's products include JELMYTO and investigational treatment UGN-102.
UroGen Pharma Ltd. (Nasdaq: URGN) has announced promising initial results from a study on UGN-102, an investigational treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). In a feasibility study, 75% of patients (6 of 8) achieved a complete response three months post-treatment. The study indicates the potential for at-home administration of UGN-102, which may alleviate patient burdens associated with frequent clinical visits. The favorable outcomes support UroGen’s ongoing Phase 3 ENVISION trial for UGN-102, with plans to submit a New Drug Application in 2024, potentially transforming treatment options for bladder cancer patients.
UroGen Pharma (NASDAQ: URGN) highlights findings from a significant study involving JELMYTO® (mitomycin), focusing on its real-world application for treating low-grade upper tract urothelial cancer (LG-UTUC). Analyzed data from 132 patients across 15 centers showcase usage trends differing from the pivotal Olympus study, with a noted 70% complete response rate for tumors <1cm. The study suggests reduced ureteric stenosis rates (23% vs. 44% in Olympus) through antegrade administration. A uTRACT Registry is underway to further examine JELMYTO's potential outcomes.
UroGen Pharma Ltd. (Nasdaq: URGN) has fully enrolled the Phase 3 ENVISION study for UGN-102, an investigational treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study aims to validate the efficacy of UGN-102 as a non-surgical primary therapeutic option, targeting 220 patients across 90 sites. If findings are positive, UroGen plans to submit a New Drug Application (NDA) for UGN-102 in 2024. This innovative therapy could significantly reduce the need for repeated surgeries and anesthesia, improving the treatment approach for bladder cancer patients.
UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of inducement restricted stock units (RSUs) to 12 new employees to support the commercial launch of Jelmyto® and the development of its pipeline. A total of up to 20,800 shares will vest over three years, contingent on continued employment. The grants adhere to Nasdaq's listing rules and UroGen's 2019 Inducement Plan. UroGen specializes in innovative treatments for urothelial and specialty cancers and is known for its RTGel™ technology.