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 Ltd. (Nasdaq:URGN), a biotech company focused on innovative solutions for urothelial and specialty cancers, will participate in the Cowen 42nd Annual Healthcare Conference on March 8, 2022, at 10:30 AM Eastern Time. The panel discussion will be available via live webcast on their website, with a replay accessible for 30 days. UroGen's proprietary RTGel™ technology enhances drug delivery for better treatment outcomes, particularly for low-grade non-muscle invasive bladder cancer. For more information, visit www.urogen.com.
UroGen Pharma Ltd. (Nasdaq: URGN) announces the publication of a retrospective analysis in the Journal of Urology on the antegrade administration of Jelmyto, the only non-surgical treatment for low-grade upper tract urothelial cancer (LG UTUC). The study outlines a stepwise protocol, emphasizing its safety and effectiveness. Conducted by a team at the University of Missouri, it involved eight patients, with promising outcomes. The findings suggest that antegrade administration could reduce complications associated with traditional methods. Further studies are encouraged to confirm these benefits.
UroGen Pharma Ltd. (NASDAQ: URGN) announced the initiation of its Phase 3 ENVISION study for UGN-102, targeting low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC). The study aims to validate UGN-102 as a primary chemoablative therapy and will enroll approximately 220 patients across 90 sites. Results will help UroGen potentially submit a New Drug Application (NDA) in 2024, depending on findings. The trial's design mirrors the successful OPTIMA II study, with a focus on complete response rates and durability over time.
UroGen Pharma Ltd. (Nasdaq: URGN) announced its participation in two virtual healthcare conferences in January. The company will present at the 40th Annual J.P. Morgan Healthcare Conference on January 13 at 9:45 a.m. ET, and its presentation will be available on-demand at the HC Wainwright BioConnect Conference starting on January 10 at 7:00 a.m. ET. Webcasts for both events will be accessible via the investors section of UroGen’s website, with replays available for 30 days.
UroGen focuses on innovative treatments for urothelial and specialty cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) has initiated a Phase 3b study of UGN-102 in patients with low-grade non-muscle invasive bladder cancer. This study aims to evaluate the feasibility of administering treatment at home, potentially enhancing access for patients, often elderly and medically complex. The study will enroll up to ten patients, with the first dose already administered. The primary endpoint is the safety profile of UGN-102.
With 80,000 annual bladder cancer cases, patient demand for less invasive options is critical, as current surgical methods are burdensome.
UroGen Pharma Ltd. (Nasdaq: URGN) announced the issuance of inducement restricted stock units (RSUs) to 13 new employees to support the commercial launch of Jelmyto® and ongoing pipeline development. A total of 53,000 shares will be available upon vesting over three years, contingent on continued employment. This grant aligns with UroGen’s 2019 Inducement Plan and complies with Nasdaq Rule 5635(c)(4). UroGen focuses on innovative solutions for specialty cancers and urologic diseases, utilizing RTGel™ technology aimed at enhancing local treatment effectiveness.
UroGen Pharma Ltd. (URGN) reported a net product revenue of $11.4 million for Q3 2021, marking over 200% growth year-over-year. The company announced a shift to a single-arm Phase 3 study for UGN-102 in bladder cancer, aiming for a NDA submission in 2024. New patient starts surged by 60% in September and October compared to prior months. Despite gains, UroGen reported a net loss of $30.2 million, with cash equivalents totaling $110.3 million as of September 30, 2021. Full-year revenue guidance ranges from $47 million to $51 million.
UroGen Pharma Ltd. (Nasdaq: URGN) announced its participation in two virtual healthcare conferences in November: the Stifel 2021 Virtual Healthcare Conference on November 17 at 9:20 a.m. ET and the Jefferies London Healthcare Conference with an on-demand Fireside Chat available starting November 18 at 3:00 a.m. ET. Webcasts for these events will be accessible via UroGen's website for 30 days. UroGen focuses on developing novel treatments for urothelial and specialty cancers, leveraging its RTGel™ technology for enhanced therapeutic profiles.
UroGen Pharma Ltd. (Nasdaq: URGN) announces plans for a single-arm Phase 3 study of UGN-102 to treat low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC), expected to start in early 2022. Approximately 220 patients will be enrolled across 90 sites, with the study intended to support a New Drug Application (NDA) by 2024. The company will halt enrollment in its ATLAS trial but will allow current participants to complete it. UroGen also discussed its pipeline, including immunotherapy candidates UGN-301 and UGN-201, during its virtual Spotlight Event.
UroGen Pharma Ltd. (NASDAQ: URGN) is hosting a virtual ‘Spotlight Event’ on November 10, 2021, at 11:00 AM ET to discuss UGN-102 and its innovative early-stage pipeline programs, including UGN-301 and UGN-302. The event will feature presentations from executives, including Chairman Arie Belldegrun, along with a Key Opinion Leader panel on NMIBC treatment. The third quarter 2021 financial results will be reported on November 15, 2021, followed by a conference call at 10:00 AM ET.