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Oppenheimer raised its price target on UroGen Pharma (NASDAQ:URGN) stock to $31.00 from $10.00 on Friday, while maintaining an Outperform rating following the approval of Zusduri. The stock, currently trading at $12.03, has seen analyst targets ranging from $3 to $47, with four analysts recently revising their earnings estimates upward according to InvestingPro data.
The significant price target increase reflects Oppenheimer’s updated outlook after Thursday’s regulatory approval of the company’s drug. During Friday’s conference call, UroGen revealed the list price for Zusduri will be $21,500 per dose. The company maintains impressive gross profit margins of nearly 90% and has demonstrated strong market momentum, with the stock surging over 50% in the past week.
The research firm noted that while clarity is still needed on the approval path for UGN-103, management does not expect potential changes to the clinical trial strategy to significantly alter its financial outlook. UGN-103 is important for extending the company’s franchise exclusivity beyond early 2031. With a healthy current ratio of 5.65, the company appears well-positioned to fund its development pipeline.
Oppenheimer’s analysis supports a product launch targeting recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer, a condition affecting approximately 59,000 U.S. patients annually. The firm projects the treatment could achieve expected performance in 2026 and eventually reach $1 billion in sales. For deeper insights into UroGen’s market potential and comprehensive financial analysis, access the full Pro Research Report available on InvestingPro.
The research firm recommends buying UroGen Pharma shares and suggests investors take advantage of any near-term weakness in the stock price. Based on InvestingPro’s Fair Value analysis, the stock currently appears to be trading near its fair value.
In other recent news, UroGen Pharma announced the FDA’s approval of ZUSDURI, a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. The approval is based on the Phase 3 ENVISION trial results, which showed a 78% complete response rate at three months, with 79% of these patients maintaining their response after a year. This marks the first FDA-approved medication specifically for this condition, potentially impacting approximately 59,000 patients in the U.S. annually. The treatment is expected to be available in the U.S. starting July 1, 2025. Despite a negative advisory committee recommendation, the FDA’s decision highlights the drug’s positive benefit/risk profile. Guggenheim raised its price target for UroGen to $30, maintaining a Buy rating, while Scotiabank (TSX:BNS) increased its price target to $47, maintaining a Sector Outperform rating. Analysts project ZUSDURI could capture 15% of the market, potentially generating significant sales in the coming years. UroGen has committed to continue the ENVISION trial and provide annual updates to the FDA.
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