Urogen Pharma Stock Price, News & Analysis

UroGen Pharma Ltd. (NASDAQ: URGN) announced at the Society of Urologic Oncology Meeting that its JELMYTO (mitomycin) treatment for low-grade upper tract urothelial carcinoma (LG-UTUC) demonstrated a median durability of response of 28.9 months in a rollover study. Of 16 patients who maintained a complete response, 13 remained disease-free, while two experienced recurrence, and one underwent nephroureterectomy. JELMYTO is positioned as a primary kidney-sparing treatment for LG-UTUC, with expectations for long-term recurrence-free survival.

UroGen Pharma Ltd. (NASDAQ: URGN) reported outcomes from a multi-center study of 32 patients undergoing antegrade administration of JELMYTO for upper tract urothelial carcinoma. The study, published in The British Journal of Urology International, revealed a 9% incidence of ureteral stenosis and a 10% discontinuation rate. Remarkably, all stenosis cases were managed without recurrence. A significant 59% of patients showed no evidence of disease at the primary disease evaluation after a median follow-up of 15 months. Overall, the study suggests a favorable safety profile for JELMYTO, emphasizing its outpatient advantages.

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.