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U.S. FDA Approves UroGen's ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)

1. ZUSDURI approved by FDA as first treatment for recurrent LG-IR-NMIBC. 2. This unique therapy may significantly enhance URGN's market position.

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FAQ

Why Very Bullish?

FDA approval can substantially increase URGN's revenue and market confidence, similar to past approvals that boosted stock prices significantly.

How important is it?

The approval of ZUSDURI positions URGN strongly in a niche market, likely leading to increased sales and investor interest.

Why Short Term?

The immediate impact from FDA approval is likely to be seen in upcoming quarterly results and analyst estimates.

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PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. ZUSDURI consists of mitomycin and sterile hydrogel, using UroGen's proprietary sustained release RTGel® technology. ZUSDURI has been designed.

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