Urogen Pharma Stock Price, News & Analysis

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.

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.