UGN-501 — IND submission
Late 2026
Investigational New Drug-enabling studies are currently ongoing, with the goal of submitting an IND and initiating a Phase 1 trial by the end of 2026.Source filing
URGN biotech catalysts & pipeline
UROGEN PHARMA LTD · Data as of 2026-09-08
Upcoming catalysts
UGN-103 — Regulatory decision
2027
We anticipate submitting an NDA for UGN-103 in the second half of 2026 with potential FDA approval in 2027.Source filing