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UroGen Announces FDA Acceptance Of IND Application For UGN-103, A Next Generation Mitomycin-Based Formulation For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Benzinga ·  Apr 15 08:11
  • UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024
  • Anticipated advantages include a new 80 mg mitomycin dosage strength that may considerably shorten the manufacturing process, simplify the reconstitution procedure, and potentially extend intellectual property protection until as late as December 2041

UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) accepted the Company's Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate...

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