Biotechnology company UroGen Pharma Ltd (Nasdaq: URGN) announced on Monday that the FDA has accepted the Investigational New Drug (IND) application for UGN-103, a novel mitomycin-based formulation targeting low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Leveraging the RTGel platform technology, UGN-103 aims to streamline production processes and enhance treatment convenience.

Plans include initiating a Phase 3 study in 2024 to evaluate safety and efficacy.

If approved, UGN-103's anticipated advantages include an 80 mg mitomycin dosage strength and potential extended intellectual property protection until December 2041.

The company is dedicated to advancing innovative solutions for urothelial and specialty cancers.