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FDA Approves Urogen Pharma’s ZUSDURI for Bladder Cancer

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FDA Approves Urogen Pharma’s ZUSDURI for Bladder Cancer

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Urogen Pharma ( (URGN) ) has issued an announcement.

On June 12, 2025, the FDA approved Urogen Pharma‘s ZUSDURI™, a sustained-release gel formulation of mitomycin, for treating adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This approval is based on the Phase 3 ENVISION trial, where 78% of patients achieved complete response at three months, with 79% maintaining it at 12 months. ZUSDURI is expected to be available in the U.S. by July 1, 2025, and Urogen Pharma has committed to further trials and updates to the FDA to assess long-term benefits.

The most recent analyst rating on (URGN) stock is a Buy with a $53.50 price target. To see the full list of analyst forecasts on Urogen Pharma stock, see the URGN Stock Forecast page.

Spark’s Take on URGN Stock

According to Spark, TipRanks’ AI Analyst, URGN is a Neutral.

Urogen Pharma’s stock score is primarily influenced by its financial performance challenges, despite strong revenue growth. The technical indicators suggest cautious trading, while the earnings call provides a mixed outlook with both promising and concerning elements. Valuation metrics underscore the high-risk nature of the investment, resulting in an overall moderate score.

To see Spark’s full report on URGN stock, click here.

More about Urogen Pharma

Average Trading Volume: 2,077,282

Technical Sentiment Signal: Buy

Current Market Cap: $336.6M

See more data about URGN stock on TipRanks’ Stock Analysis page.

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