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UroGen Pharma Ltd. (Nasdaq: URGN) is a clinical-stage biopharmaceutical company dedicated to developing innovative non-surgical treatments for urological conditions, particularly uro-oncology. The company is headquartered in Ra’anana, Israel, with its U.S. headquarters in New York.
UroGen’s core technology, RTGel™, is a proprietary sustained-release, hydrogel-based platform designed to improve drug delivery and efficacy. By prolonging the exposure of the urinary tract tissue to medications, RTGel™ aims to make local therapies more effective. This innovative approach addresses significant unmet needs in the field of urology.
The company’s lead product candidates include Mitogel™ (mitomycin urothelial gel) and Vesigel™ (mitomycin intravesical gel). Both products target non-surgical tumor ablation in non-muscle invasive urothelial cancers. Mitogel™ is specifically designed to treat low-grade upper tract urothelial carcinoma, while Vesigel™ aims to treat bladder cancer.
Additionally, UroGen's commercial product, Jelmyto (mitomycin) for pyelocalyceal solution, has shown promise in treating patients. Their investigational candidate, UGN-102 (mitomycin) for intravesical solution, is in development for bladder cancer treatment.
UroGen is also advancing its immuno-uro-oncology pipeline with UGN-301 (zalifrelimab), an anti-CTLA-4 antibody, which is being explored for both monotherapy and combination therapy.
Through strategic partnerships, cutting-edge research, and a commitment to addressing complex medical challenges, UroGen Pharma continues to push the boundaries in the treatment of urothelial diseases.
UroGen Pharma Ltd. (Nasdaq: URGN) reported its Q4 and full-year 2020 financial results, marking a significant transition with the launch of Jelmyto, achieving $8.0 million in Q4 product revenue and $11.8 million since its launch on June 1, 2020. The company initiated the Phase 3 ATLAS trial for UGN-102 and established a collaboration with MD Anderson for UGN-302. UroGen reported a net loss of $30.5 million for Q4 2020 and $128.5 million for the full year, with cash reserves of $103.9 million as of December 31, 2020. Guidance for 2021 operating expenses is $155 to $170 million.
UroGen Pharma Ltd. (Nasdaq: URGN) has secured a strategic funding agreement with RTW Investments, LP, receiving $75 million upfront. The agreement entails tiered future cash payments based on global sales of Jelmyto® and UGN-102, contingent on specific sales milestones. Future payments will cease once RTW receives a total of $300 million. UroGen aims to utilize this non-dilutive funding to bolster the launch of Jelmyto and advance the ongoing Phase 3 ATLAS study for UGN-102, reflecting its commitment to developing treatments for urologic cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) announced a research agreement with Johns Hopkins University to explore immunotherapy for glioblastoma multiforme (GBM) using RTGel™ technology. This proprietary hydrogel aims to enhance drug exposure and efficacy in local immunotherapy delivery. The research, expected to start in Q2 2021, focuses on using checkpoint inhibitors to combat GBM, which has a less than 5% five-year survival rate. UroGen's advancements in immuno-oncology include UGN-302 for high-grade non-muscle invasive bladder cancer.
UroGen Pharma Ltd. (Nasdaq: URGN) announces the release of its fourth quarter and full year 2020 financial results on March 18, 2021, before market opening. This will be followed by a live audio webcast and conference call at 8:30 AM ET. UroGen is focused on innovative solutions for specialty cancers and urologic diseases, with its first commercial product, UGN-102, aimed at treating low-grade non-muscle invasive bladder cancer. The company utilizes its proprietary RTGel™ technology to enhance drug efficacy through sustained release in the urinary tract.
UroGen Pharma Ltd. (Nasdaq: URGN) has granted inducement restricted stock units (RSUs) to nine new employees to support the launch of Jelmyto® and ongoing pipeline development. Up to 38,500 shares of common stock will be issued upon RSU vesting, occurring over three years. The grant complies with Nasdaq Rule 5635(c)(4) and is part of UroGen's 2019 Inducement Plan. UroGen focuses on innovative solutions for specialty cancers and urologic diseases, utilizing technologies like RTGel™ to enhance drug efficacy. For more details, visit www.urogen.com.
UroGen Pharma Ltd. (Nasdaq:URGN) has announced its participation in two virtual conferences in March 2021. The Cowen 41st Annual Health Care Conference will take place on March 2 at 9:10 AM Eastern Time, followed by the Oppenheimer 31st Annual Healthcare Conference on March 16 at 1:10 PM Eastern Time. Each event will be webcast live, with replays available on the company’s website for approximately 30 days. UroGen specializes in developing innovative solutions for treating specialty cancers and urologic diseases, including its investigational treatment UGN-102.
UroGen Pharma Ltd. (Nasdaq: URGN) announced a strategic three-year collaboration with The University of Texas MD Anderson Cancer Center to advance intravesical immunotherapy for high-grade non-muscle invasive bladder cancer (HG-NMIBC). The partnership focuses on UGN-201 and UGN-301, utilizing UroGen's RTGel™ platform for enhanced treatment efficacy. The collaboration aims to design and conduct clinical studies to potentially improve patient outcomes and expand therapeutic options in a market with significant unmet needs.
UroGen Pharma Ltd. (Nasdaq:URGN) has announced that its President and CEO, Liz Barrett, will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 4:30 p.m. ET. The presentation will be webcasted live and can be accessed via the Investors & Media section on UroGen's website, with a replay available for 30 days. UroGen focuses on innovative treatments for specialty cancers and urologic diseases, including its approved product, Jelmyto, and investigational treatment UGN-102, both targeting non-muscle invasive urothelial cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of inducement restricted stock units (RSUs) to nine new employees. These RSUs, totaling up to 35,300 shares, will vest over three years, aiding in the ongoing launch of Jelmyto® (mitomycin) for pyelocalyceal solution and the company's pipeline development. The grants comply with Nasdaq listing Rule 5635(c)(4) and are part of UroGen's 2019 Inducement Plan. UroGen focuses on innovative therapies for specialty cancers and urologic diseases, including the non-surgical treatment of urothelial cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) announced that the Centers for Medicare & Medicaid Services (CMS) will implement a permanent J-code for Jelmyto (mitomycin) effective January 1, 2021. This new J-code replaces a temporary C-code and aims to enhance standardization and reimbursement processes for hospitals and physicians. Jeffrey Bova, UroGen's Chief Commercial Officer, highlighted that this change will simplify billing and improve access to Jelmyto for patients with low-grade upper tract urothelial cancer. The J-code is expected to streamline billing across various care settings.
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