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 May 2, 2023 from 10:00 AM ET. This event aims to showcase UroGen's dedication to developing innovative treatments for urothelial and specialty cancers.
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 location value="LU/us.nj.prnctn"Princeton, NJ, and operates in location value="LC/il"Israel.
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.