UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

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-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The UGN-103 formulation uses UroGen’s RTGel platform technology, a proprietary sustained-release, reverse-thermal hydrogel that can improve the therapeutic profiles of existing drugs. UGN-103 is anticipated to provide several advantages related to production, cost, supply, and product convenience if approved. UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 for the treatment of LG-IR-NMIBC, a highly recurrent disease.

“We are delighted by the FDA's acceptance of our IND for UGN-103, marking a significant step forward in our mission,” said Liz Barrett, President and Chief Executive Officer of UroGen. “We eagerly anticipate commencing a clinical trial with UGN-103 this year, as we strive to continually advance and develop treatments for patients with high unmet need.”

UGN-103 is planned to follow the anticipated FDA approval and launch of UGN-102 (mitomycin) for intravesical solution for LG-IR-NMIBC. UroGen intends to complete the rolling new drug application (NDA) submission for UGN-102 in September 2024, with a potential FDA decision as early as the first quarter of 2025 if priority review is granted by FDA.

About UGN-103

UGN-103 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin being developed for the treatment of LG-IR-NMIBC. UroGen plans to initiate a Phase 3 study to explore the safety and efficacy of UGN-103 in 2024. Anticipated advantages of UGN-103 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. UGN-103 will utilize UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.