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
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UroGen Pharma Ltd. (NASDAQ:URGN) announced FDA acceptance of its IND application for UGN-103, a novel mitomycin-based formulation for treating low-grade intermediate-risk non-muscle invasive bladder cancer. UroGen plans to initiate a Phase 3 study in 2024, with potential advantages including a new 80 mg dosage strength, simplified manufacturing, and extended intellectual property protection until December 2041. UGN-103 utilizes UroGen's RTGel platform technology. Additionally, UroGen is preparing for an NDA submission for UGN-102, another mitomycin formulation, in September 2024.
April 15, 2024 | 12:11 pm
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UroGen Pharma's FDA acceptance of the IND application for UGN-103 and plans for a Phase 3 study in 2024 could positively impact investor sentiment, given the potential market expansion and extended IP protection.
FDA acceptance of UGN-103's IND application and the planned Phase 3 study indicate significant progress in UroGen's pipeline, potentially leading to market expansion and extended IP protection. This development could enhance investor sentiment and possibly lead to a positive short-term impact on URGN's stock price, considering the importance of new product pipelines in the biotech sector.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100