UroGen Pharma Ltd.
UGN-103
recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
Date
TBD
FDA decision · Date TBD estimated
What's at stake
The FDA's approval decision on UGN-103 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer is due Date TBD. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 14h ago
“UroGen plans to submit a New Drug Application (NDA) for UGN-103 (mitomycin) for recurrent LG-IR-NMIBC in the second half of 2026 with potential FDA approval in 2027.”