UroGen Pharma Receives FDA Approval for ZUSDURI for Recurrent Bladder Cancer

UroGen Pharma Ltd. (NASDAQ:URGN) is one of the best hot stocks to buy according to Wall Street analysts. In mid-June, UroGen Pharma announced that the US FDA had approved ZUSDURI (mitomycin) for intravesical solution. This marked ZUSDURI as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

ZUSDURI was formerly known as UGN-102 and is an innovative drug formulation of mitomycin combined with a sterile hydrogel, using UroGen’s proprietary sustained-release RTGel technology. This design allows for potent tumor ablation through non-surgical means, delivered directly into the bladder via a urinary catheter in an outpatient procedure by a trained healthcare professional.

UroGen Pharma Receives FDA Approval for ZUSDURI for Recurrent Bladder Cancer

A scientist examining a sample of hydrogel in a laboratory setting.

The approval is supported by positive results from the pivotal Phase 3 ENVISION trial. The trial demonstrated that 78% of patients achieved a complete response at 3 months. Furthermore, 79% of those responders maintained their complete response at 12 months after the 3-month visit. The medication exhibited a manageable safety profile as well.

UroGen Pharma Ltd. (NASDAQ:URGN) develops and commercializes solutions for urothelial and specialty cancers.

While we acknowledge the potential of URGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.