UroGen Pharma Ltd.URGN shares traded decrease Wednesday after the Oncologic Medication Advisory Committee (ODAC) of the Meals and Drug Administration voted towards the profit/danger of UGN-102 (mitomycin) for intravesical resolution.
What To Know: The committee voted 4 sure to 5 no that the profit/danger of UGN-102 for intravesical resolution was favorable for the therapy of recurrent Low-Grade Intermediate-Danger Non-Muscle Invasive Bladder Most cancers.
The vote comes after the committee reviewed medical knowledge supporting the efficacy and security of UGN-102, together with the outcomes from the Section 3 ENVISION examine.
Liz Barrett, president and CEO of UroGen, stated, “Whereas we’re upset by immediately’s final result, we proceed to consider our medical knowledge assist UGN-102 for the therapy of recurrent LG-IR-NMIBC, a illness with no FDA-approved therapies. The FDA rigorously considers the impartial recommendation from ODAC, and we look ahead to working with the FDA as they full their evaluate of the applying for UGN-102.”
URGN Value Motion: UtroGen inventory closed 44.69% decrease at $4.17, in response to knowledge from Benzinga Professional.
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