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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) will release its third quarter 2022 financial results on November 10, 2022, before the market opens. Following this, a conference call and live audio webcast will be held at 10:00 AM ET. UroGen focuses on developing treatments for urothelial and specialty cancers, utilizing innovative technologies like their RTGel™ platform. This technology aims to improve local therapy effectiveness. Their products include Jelmyto® for pyelocaliceal solution and investigational UGN-102 for intravesical solution.
UroGen Pharma Ltd. (NASDAQ: URGN) is set to host a webinar on October 18, 2022, at 9:00 AM ET, discussing its investigational drug UGN-102 for treating low-grade intermediate-risk non-muscle-invasive bladder cancer (NMIBC). Key opinion leaders, Dr. Gary D. Steinberg and Dr. William C. Huang, will present insights on the unmet medical needs and current treatments in NMIBC. UGN-102 leverages the RTGel™ Technology and is in Phase 3 development, potentially revolutionizing treatment options for approximately 35,000 low-grade NMIBC patients annually in the U.S.
UroGen Pharma Ltd. (Nasdaq: URGN) announced that the FDA has authorized an extension of the in-use period for JELMYTO (mitomycin) from 8 hours to 96 hours after reconstitution. This allows for greater logistical flexibility for healthcare providers and enhances access for patients with low-grade upper-tract urothelial cancer (LG UTUC). The new guidelines will streamline patient care and scheduling, aligning with UroGen's goal of improving treatment delivery.
UroGen Pharma (NASDAQ: URGN) has appointed Dr. Leana S. Wen to its Board of Directors, effective immediately. Dr. Wen is an emergency medicine physician and public health expert, currently a professor at George Washington University. Her experience includes serving as Baltimore's health commissioner, where she tackled significant health issues. UroGen's CEO, Liz Barrett, highlighted that Dr. Wen's expertise will enhance the company's mission in uro-oncology. With a focus on innovative treatments, UroGen aims to meet the unmet needs in the field.
UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of up to 43,300 inducement restricted stock units (RSUs) to 10 new employees as part of their employment. These RSUs will vest over three years, supporting the launch of Jelmyto® for treating pyelocalyceal solution and the company's ongoing pipeline development. This initiative aims to enhance their team to further innovate in the treatment of urothelial and specialty cancers, demonstrating UroGen's commitment to advancing therapeutic options for patients.
UroGen Pharma Ltd. (Nasdaq: URGN) announced its participation in two healthcare conferences in September: the H.C. Wainwright & Co. Annual Global Investment Conference on September 13 and the Ladenburg Thalmann Healthcare Conference on September 29. Both presentations will be accessible via webcasts on UroGen’s website, where replays will be available for 30 days. UroGen focuses on innovative treatments for urothelial and specialty cancers, leveraging proprietary technologies like RTGel™ for local therapies that enhance drug effectiveness.
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.
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