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UroGen Pharma (NASDAQ:URGN), which has seen its stock surge over 50% in the past week according to InvestingPro data, received full FDA approval for its bladder cancer treatment Zusduri on Thursday, one day ahead of its scheduled decision date and despite a negative advisory committee recommendation last month. The approval covers recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, representing a potential market of 59,000 patients annually. The company, currently valued at approximately $511 million, maintains impressive gross profit margins of nearly 90%.
The regulatory decision came as a surprise to many observers, as the FDA typically follows the recommendations of its advisory committees in approximately 88% of cases. The Oncologic Drugs Advisory Committee had voted 4-5 against approval during its May meeting. InvestingPro data shows that four analysts have recently revised their earnings estimates upward, suggesting growing confidence in the company’s prospects.
Guggenheim raised its price target on UroGen stock to $30.00 from $15.00 on Friday while maintaining a Buy rating. The firm cited the broad indication approval without requirements for additional large randomized controlled trials as a "best-case scenario" for the company.
UroGen announced Zusduri will be commercially available starting July 1. The company’s only post-marketing commitment involves completing the ongoing ENVISION trial with annual updates on duration of response for patients with ongoing complete responses.
Guggenheim now projects Zusduri could capture 15% of the market, potentially generating approximately $800 million in U.S. sales at peak in 2030. The firm increased its probability of success assumption for the drug to 100% from its previous 20% estimate.
In other recent news, UroGen Pharma has received FDA approval for ZUSDURI, a treatment for recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This approval marks ZUSDURI as the first intravesical medication for this condition, impacting approximately 59,000 patients in the U.S. annually. The approval is based on Phase 3 trial results showing a 78% complete response rate at three months, with 79% of responders maintaining this response a year later. Following the FDA’s decision, Scotiabank (TSX:BNS) raised UroGen Pharma’s stock price target from $23 to $47, maintaining a Sector Outperform rating. The investment bank cited the drug’s market potential, estimating a peak opportunity of around $1 billion. Meanwhile, Oppenheimer adjusted its price target for UroGen Pharma to $10 from $36, maintaining an Outperform rating, reflecting an updated financial model. UroGen Pharma also presented promising findings from its ENVISION and ATLAS studies at a recent oncology meeting. These developments could influence future treatment approaches for bladder cancer, with the market closely watching upcoming regulatory milestones.
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