On Friday, UroGen Pharma (NASDAQ:URGN) shares saw its price target increased by Ladenburg Thalmann from $48.00 to $53.50, retaining a Buy rating on the stock. The revision follows the recent disclosure of strong 12-month Duration of Response (DoR) data from the ENVISION trial at an investor event held on Thursday. UroGen Pharma's UGN-102, a treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer, demonstrated an 82.3% DoR at the 12-month mark.
The ENVISION trial, a Phase 3 study, enrolled 240 patients with previously diagnosed Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer who had undergone a prior transurethral resection of bladder tumor (TURBT) and were being evaluated for the safety and efficacy of UGN-102 as a primary chemo ablative therapy. The primary endpoint of the study was the complete response rate at the 3-month visit, which was reported at an impressive 79.6%.
UroGen Pharma announced that the rolling submission of a New Drug Application (NDA) is expected to be completed by September 2024, with the potential for approval in the first quarter of 2025, especially if granted priority review. The robust trial data suggests a favorable outlook for UGN-102, with a predicted median DoR estimated to be 40 months.
The company's report highlighted that the 12-month DoR of 82.3% for UGN-102 outperformed a comparable subpopulation in the ATLAS trial, which had a 12-month DoR of 66%. Moreover, the DoR Kaplan Meier estimates at 15 and 18 months remained consistent at 80.9%, with the median DoR not estimable but predicted to extend to 40 months, indicating a strong and consistent efficacy profile for the treatment.
InvestingPro Insights
Following UroGen Pharma's positive trial results, a closer look at the company's financial metrics and analyst insights from InvestingPro provides a broader perspective on URGN's market position. The company boasts a market capitalization of $632.28 million and has shown a notable revenue growth of 24.0% in the last twelve months as of Q1 2024. Furthermore, UroGen Pharma's impressive gross profit margin stands at 89.53% for the same period, underlining the company's ability to efficiently manage its production costs relative to its sales.
InvestingPro Tips for URGN highlight the company's financial health, with more cash than debt on its balance sheet and liquid assets surpassing short-term obligations, which could provide financial flexibility in the upcoming drug approval process. However, it's important to note that analysts have revised their earnings downwards for the upcoming period, and the company is not expected to be profitable this year. Additionally, the stock has experienced significant returns over the last week, month, and three months, with a 1-week price total return of 32.48% and a 1-month return of 34.93%.
For investors looking to delve deeper into UroGen Pharma's performance and future prospects, there are additional InvestingPro Tips available for URGN at https://www.investing.com/pro/URGN. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and explore the full range of analytical tools and insights that InvestingPro has to offer. With 10 more tips listed, investors can gain a comprehensive understanding of URGN's investment potential.
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