UroGen Pharma (URGN) shares tumbled 48% in recent Wednesday trading after the company said its UGN-102 bladder cancer drug failed to receive the backing of a US Food and Drug Administration advisory committee.
The new drug application for UGN-102 is currently under review by the FDA with a decision expected on June 13, the company said Wednesday in a statement.
"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," UroGen Pharma Chief Executive Officer Liz Barrett said in the statement.
"The FDA carefully considers the independent advice" from the Oncologic Drugs Advisory Committee, and "we look forward to working with the FDA as they complete their review of the application for UGN-102," Barrett said.
UGN-102, or mitomycin, is designed to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Price: 3.91, Change: -3.63, Percent Change: -48.14
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