Urogen Pharma Stock Price, News & Analysis

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.

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.