UroGen Pharma Ltd. develops and commercializes therapies for urothelial and specialty cancers, with recurring updates centered on approved mitomycin products and its RTGel® reverse-thermal hydrogel platform. Company announcements commonly address JELMYTO for low-grade upper tract urothelial cancer and ZUSDURI for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, including product revenue, reimbursement coding, physician education and real-world treatment experience.
UroGen news also covers clinical data publications, pipeline programs such as UGN-103 and UGN-501, research and development spending, debt financing, employee equity inducement grants and investor-conference participation. The company’s updates connect commercial execution with sustained-release local therapy designed to increase urinary tract tissue exposure to medication.
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.
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.