UroGen Pharma Ltd. Ordinary Shares - URGN STOCK NEWS

UroGen Pharma Ltd. (Nasdaq: URGN) has announced promising initial results from a study on UGN-102, an investigational treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). In a feasibility study, 75% of patients (6 of 8) achieved a complete response three months post-treatment. The study indicates the potential for at-home administration of UGN-102, which may alleviate patient burdens associated with frequent clinical visits. The favorable outcomes support UroGen’s ongoing Phase 3 ENVISION trial for UGN-102, with plans to submit a New Drug Application in 2024, potentially transforming treatment options for bladder cancer patients.

UroGen Pharma (NASDAQ: URGN) highlights findings from a significant study involving JELMYTO^® (mitomycin), focusing on its real-world application for treating low-grade upper tract urothelial cancer (LG-UTUC). Analyzed data from 132 patients across 15 centers showcase usage trends differing from the pivotal Olympus study, with a noted 70% complete response rate for tumors <1cm. The study suggests reduced ureteric stenosis rates (23% vs. 44% in Olympus) through antegrade administration. A uTRACT Registry is underway to further examine JELMYTO's potential outcomes.

UroGen Pharma Ltd. (Nasdaq: URGN) has fully enrolled the Phase 3 ENVISION study for UGN-102, an investigational treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study aims to validate the efficacy of UGN-102 as a non-surgical primary therapeutic option, targeting 220 patients across 90 sites. If findings are positive, UroGen plans to submit a New Drug Application (NDA) for UGN-102 in 2024. This innovative therapy could significantly reduce the need for repeated surgeries and anesthesia, improving the treatment approach for bladder cancer patients.

UroGen Pharma Ltd. (Nasdaq: URGN) announced the grant of inducement restricted stock units (RSUs) to 12 new employees to support the commercial launch of Jelmyto® and the development of its pipeline. A total of up to 20,800 shares will vest over three years, contingent on continued employment. The grants adhere to Nasdaq's listing rules and UroGen's 2019 Inducement Plan. UroGen specializes in innovative treatments for urothelial and specialty cancers and is known for its RTGel™ technology.

UroGen Pharma Ltd. (Nasdaq: URGN) presented data from the OPTIMA II study at the 23rd Annual Society of Urological Oncology Meeting in San Diego, indicating a median duration of response (DOR) of 24.4 months for its investigational drug UGN-102 in treating low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This study involved 15 patients, with 7 maintaining complete response (CR). The innovative UGN-102 is seen as a non-surgical treatment alternative, addressing the high recurrence rates typical with current options.

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.