UroGen Pharma Ltd.
UGN-103
recurrent LG-IR-NMIBC
Date
TBD
FDA decision · Date TBD estimated
What's at stake
An FDA complete response letter on UGN-103 for recurrent LG-IR-NMIBC is in focus around Date TBD.
Primary source
· SEC 8-K
verified 16h ago
“The data from the UTOPIA trial may not be sufficient to support approval of UGN-103.”