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 2026-10-25
Upcoming catalysts
UGN-103 — PDUFA
Jun 14
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.Source filing