What's Going On With UroGen Pharma Stock Wednesday?

UroGen Pharma Ltd.URGN shares traded lower Wednesday after the Oncologic Drugs Advisory Committee (ODAC) of the Food and Drug Administration voted against the benefit/risk of UGN-102 (mitomycin) for intravesical solution.

What To Know: The committee voted four yes to five no that the benefit/risk of UGN-102 for intravesical solution was favorable for the treatment of recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer.

The vote comes after the committee reviewed clinical data supporting the efficacy and safety of UGN-102, including the results from the Phase 3 ENVISION study.

Liz Barrett, president and CEO of UroGen, said, “While we are disappointed by today’s outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies. The FDA carefully considers the independent advice from ODAC, and we look forward to working with the FDA as they complete their review of the application for UGN-102.”

URGN Price Action: UtroGen stock closed 44.69% lower at $4.17, according to data from Benzinga Pro.

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