UroGen Pharma Ltd.
0 products tracked · names used in filings: UroGen Pharma Ltd.
Upcoming milestones
UGN-103: PDUFA target action date (recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC))
UroGen Pharma Ltd. (URGN); mitomycin; NDA; status: set; "…The FDA accepted UroGen ’ s NDA for UGN-103 (next-generation novel mitomycin-based formulation) for review; PDUFA goal date set for June 14, 2027 • Announced first patient dosed in the UGN-501 Phase 1 trial • Conference call and webcast to be held today at 10:00 AM ET PRINCETON, N.J., Nov."; filed 2026-11-04 · source
Recent milestones
UGN-102: PDUFA target action date (recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC))
UroGen Pharma Ltd. (URGN); mitomycin; NDA; status: set; "UroGen Pharma Reports First Quarter 2025 Financial Results and Provides a Business Update ● New Drug Application for UGN-102 on track for FDA-PDUFA target action date of June 13, 2025; assuming approval, commercial launch to immediately follow with product availability in July ● Oncologic Drugs Advisor"; filed 2025-05-12 · source
Products
No products recorded.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.