Welcome to our dedicated page for Urogen Pharma news (Ticker: URGN), a resource for investors and traders seeking the latest updates and insights on Urogen Pharma stock.
UroGen Pharma Ltd. (URGN) is a biotechnology company whose news flow centers on therapies for urothelial and specialty cancers. Company announcements highlight the development and commercialization of RTGel®-based mitomycin formulations and other oncology candidates designed for non-surgical tumor ablation in the urinary tract.
On this page, readers can follow news about Jelmyto for low-grade upper tract urothelial cancer and ZUSDURI™ (mitomycin) for intravesical solution, described by UroGen as the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Updates often cover regulatory milestones such as U.S. Food and Drug Administration approvals, the assignment of a permanent HCPCS Level II J Code (J9282) for ZUSDURI, and coverage or reimbursement developments that affect access to treatment.
UroGen’s disclosures also include clinical trial results and pipeline progress, including data from the Phase 3 UTOPIA trial of UGN-103 for recurrent LG-IR-NMIBC, the clinical development program for ZUSDURI across studies such as OPTIMA II, ATLAS, and ENVISION, and ongoing work on next-generation candidates UGN-104 and UGN-501. Investors and healthcare professionals can track conference presentations, financial result releases, and corporate updates, such as inducement equity grants and proxy-related matters.
By reviewing the URGN news feed on Stock Titan, users can monitor how UroGen’s RTGel platform, approved products, and late-stage pipeline evolve over time, and how regulatory, clinical, and commercial developments may influence the company’s oncology portfolio.
UroGen Pharma Ltd. (Nasdaq: URGN) reported Q3 2022 financials, highlighting a 41% increase in JELMYTO® net product revenue, reaching $16.1 million. The FDA approved extending the in-use period for JELMYTO admixture from 8 to 96 hours, enhancing workflow for urologists. Full enrollment for the ENVISION Phase 3 trial of UGN-102 in low-grade, intermediate-risk non-muscle invasive bladder cancer is expected by the end of November 2022. Despite lower revenue compared to Q2, the company remains optimistic about market potential and growth opportunities.
UroGen Pharma Ltd. (Nasdaq: URGN) has appointed Dan Wildman to its Board of Directors. Wildman, a seasoned veteran in the medical device industry, brings over 40 years of experience, including strategic leadership roles at Johnson & Johnson and Boston Scientific. His expertise in transforming business strategies and innovations in urologic oncology is expected to enhance UroGen's development of treatments for urothelial cancers. The company specializes in innovative solutions such as RTGel™, potentially improving therapeutic outcomes for patients.
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
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