BiQ: FDA Approves Zusduri (UGN-102) (URGN)

I'm very pleased to see that the FDA did the right thing here. Everything about the data supported an approval. This is a big win for patients, investors, and the FDA--and, of course, BiQ members.

Congratulations to all BiQ members who had the courage to stick with it through all the drama!

FDA approves mitomycin intravesical solution for recurrent low-grade

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade

FDACenter for Drug Evaluation and Research

Please refer to the BiQAP Live spreadsheet on the Active Portfolio page or the iQCS for additional information.

URGN share price at time of publication: $7.17

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