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Investing.com - H.C. Wainwright has reiterated a Buy rating and $50.00 price target on UroGen Pharma (NASDAQ:URGN), representing significant upside potential from current levels, following the completion of patient enrollment in a key clinical trial. According to InvestingPro data, the stock has shown strong momentum with a 22% return over the past six months.
UroGen announced it has completed enrollment of 99 patients across multiple global centers in its Phase 3 UTOPIA (EGX:UTOP) clinical trial of UGN-103, a next-generation mitomycin formulation for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The company maintains impressive gross profit margins of nearly 90%, though InvestingPro analysis indicates it is currently unprofitable with significant R&D investments.
UGN-103 utilizes the company’s proprietary RTGel technology, a reverse-thermal hydrogel that enables sustained drug release and prolonged bladder exposure, with improvements over ZUSDURI including a shorter manufacturing process and simplified reconstitution procedure.
H.C. Wainwright expects data from the UTOPIA trial in the coming months, which could lead to an FDA filing next year and potential U.S. approval by 2027, with patent protection extending to December 2041.
The research firm notes that UroGen also plans to initiate a Phase 3 trial for UGN-104, its next-generation product for low-grade upper tract urothelial carcinoma, in the coming days.
In other recent news, UroGen Pharma has completed patient enrollment for its Phase 3 UTOPIA trial, which is evaluating UGN-103 for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The trial involves 99 patients and aims to improve upon the existing treatment, ZUSDURI, utilizing the same RTGel technology. In a significant development, the U.S. Food and Drug Administration (FDA) has approved UroGen’s ZUSDURI for the same condition, following promising results from the Phase 3 ENVISION trial, which demonstrated a 78% complete response rate at three months.
Following the FDA approval, UroGen Pharma awarded special bonuses to three executive officers, recognizing their leadership contributions. Additionally, H.C. Wainwright upgraded UroGen Pharma’s stock rating from neutral to buy, setting a price target of $50.00. Oppenheimer also raised its price target for UroGen Pharma from $10.00 to $31.00, maintaining an Outperform rating. The firm noted that UGN-103 is crucial for extending the company’s product exclusivity.
UroGen Pharma plans to launch ZUSDURI in the U.S. by July 1, 2025, with a list price of $21,500 per dose. The company has also committed to continue the ENVISION trial to further assess the treatment’s benefits. These developments highlight UroGen’s ongoing efforts to advance treatments for bladder cancer and strengthen its market position.
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