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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) presented new data at the 2022 American Urological Association annual meeting in New Orleans. The study highlights the effectiveness of the antegrade approach via nephrostomy tube for administering JELMYTO (mitomycin) in treating low-grade upper tract urothelial cancer. This method showed promising safety and efficacy data, demonstrating a complete response in 50% of patients. Although the study was retrospective and limited in size, it adds valuable real-world evidence to support treatment options for patients.
UroGen Pharma Ltd. (Nasdaq: URGN) will showcase data on JELMYTO® (mitomycin) for treating low-grade upper tract urothelial cancer at the 2022 AUA Annual Meeting in New Orleans, scheduled from May 13-16. Significant presentations will include findings from the Phase 2b OPTIMA II trial highlighting health-related quality of life impacts. JELMYTO is noted for being the only non-surgical treatment option. The presentations will be published in the June 2022 issue of The Journal of Urology.
UroGen Pharma Ltd. (URGN) reported a significant 81% increase in net product revenue for Jelmyto, reaching $13.6 million in Q1 2022 compared to Q1 2021. The company is advancing its clinical pipeline, with enrollment in the Phase 3 ENVISION trial for UGN-102 nearing completion by year-end 2022. Additionally, a new multi-arm Phase 1 trial for UGN-301 has been initiated. Despite revenue growth, UroGen reported a net loss of $28.4 million, up from $25.9 million in the same quarter last year. Expected full-year 2022 revenues are projected between $70 million and $80 million.
UroGen Pharma Ltd. (Nasdaq: URGN) is set to report its first quarter 2022 financial results on May 10, 2022, before market opening. Following the announcement, there will be a live audio webcast and conference call at 10:00 AM ET. UroGen is focused on developing innovative treatments for urothelial and specialty cancers, leveraging its proprietary RTGel™ technology for sustained drug release. The company aims to enhance local therapy effectiveness in bladder cancer treatments with its products, including Jelmyto® and investigational UGN-102.
UroGen Pharma Ltd. announced FDA clearance for its IND application to start a Phase 1 clinical study of the anti-CTLA-4 immunotherapy UGN-301 (zalifrelimab) for recurrent non-muscle invasive bladder cancer (NMIBC). The multi-arm study aims to determine the safety and recommended Phase 2 dose of monotherapy and combination therapy. UroGen plans to utilize its proprietary RTGel™ technology for intravesical delivery, targeting high-grade NMIBC. The study is expected to commence in April, enhancing treatment options for patients with limited responses to existing therapies.
UroGen Pharma Ltd. (Nasdaq: URGN) reported a 42% increase in net product revenue for Jelmyto, reaching $16.2 million in Q4 2021 and $48.0 million for the full year. The company has secured a $100 million senior secured term loan to support operations aiming for cash flow breakeven by 2025. The first patient has been dosed in the ENVISION Phase 3 trial for UGN-102 in bladder cancer. Despite a net loss of $28.5 million in Q4 and $110.8 million for the year, UroGen anticipates 2022 revenues of $70 to $80 million.
UroGen Pharma Ltd. (Nasdaq: URGN) has secured a term loan facility of up to $100 million with Pharmakon Advisors. The loan will be drawn in two tranches: $75 million available within 10 business days and an optional $25 million before December 31, 2022. This financing aims to bolster UroGen's financial position, supporting the ongoing launch of Jelmyto and clinical studies for UGN-102 and UGN-301. The reporting of Q4 and full-year financial results has been rescheduled to March 21, 2022.
UroGen Pharma Ltd. (Nasdaq: URGN) has granted inducement restricted stock units (RSUs) to 12 new employees to support the commercial launch of Jelmyto® and ongoing pipeline development. The RSUs, totaling up to 39,100 shares, will vest over three years, contingent upon continued employment. This grant follows Nasdaq listing Rule 5635(c)(4) and emphasizes UroGen's commitment to expanding its workforce for innovative cancer treatments.
UroGen Pharma Ltd. (Nasdaq: URGN) will announce its fourth quarter and full-year 2021 financial results on March 10, 2022, prior to market open. Following the announcement, a live audio webcast and conference call will be held at 10:00 AM ET. UroGen focuses on innovative treatments for urothelial and specialty cancers, with products like Jelmyto and the investigational UGN-102. These therapies utilize RTGel™, a proprietary hydrogel technology intended to enhance drug delivery in the urinary tract.
UroGen Pharma Ltd. (Nasdaq: URGN) has submitted an Investigational New Drug (IND) application for UGN-301 (zalifrelimab) to the FDA to initiate a multi-arm, Phase I clinical study to treat recurrent non-muscle invasive bladder cancer (NMIBC). This study aims to evaluate the safety and tolerability of UGN-301 as a monotherapy and in combination with other treatments. The application follows positive preclinical data suggesting that intravesical delivery may provide clinical benefits, with the study expected to commence in Q2 2022.
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