NasdaqGM:URGNBiotechs
UGN-103 Phase 3 Success and FDA Support Could Be a Game Changer for UroGen Pharma (URGN)
In early November 2025, UroGen Pharma reported third-quarter results, highlighted by preliminary Phase 3 data showing a 77.8% complete response for UGN-103 in treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, and received FDA feedback supporting a potential New Drug Application for this therapy.
This regulatory milestone not only validates UroGen’s clinical development approach but also indicates a clearer path toward new product approvals in the urothelial...