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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 reported second quarter 2022 net product revenue from Jelmyto of $16.6 million, marking a 22% increase from Q1 2022 and a 28% increase year-over-year.
The company reaffirmed its 2022 revenue guidance, expecting $70-$80 million in total. Clinical trials for UGN-102 are on track, with enrollment expected to complete by year-end 2022. The company is targeting cash flow break-even by 2025. However, a net loss of $26.7 million was reported for the quarter, while cash equivalents totaled $112.4 million as of June 30, 2022.
UroGen Pharma Ltd. (Nasdaq: URGN) will announce its Q2 2022 financial results on
UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of inducement restricted stock units (RSUs) and options to 16 new employees as part of their ongoing commercial launch of Jelmyto® and pipeline development. A total of 53,000 shares will be available through RSUs, while 12,000 shares are associated with options, both vesting over three years. These grants comply with Nasdaq rules, aimed at incentivizing new talent to enhance UroGen's capabilities in treating urothelial and specialty cancers.
UroGen Pharma Ltd. (Nasdaq: URGN) announces participation in two healthcare conferences: the H.C. Wainwright & Co. Global Investment Conference on May 25 at 11:00 a.m. ET and the Jefferies Healthcare Conference on June 9 at 1:00 p.m. ET. Webcasts for both events will be accessible on UroGen's website, with replays available for 30 days. UroGen focuses on developing innovative solutions for urothelial and specialty cancers, utilizing its proprietary RTGel™ technology for improved treatment options.
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.
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