UroGen Pharma Says The Latest DOR Data Is Expected To Support A New Drug Application For UGN-102 For Low-grade Intermediate-Risk Non-muscle Invasive Bladder Cancer, Which The Company Plans To Complete In The Very Near Term. There Is Potential For An FDA Decision As Early As Q1 Of 2025, Assuming Priority Review
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UroGen Pharma announced that the latest Duration of Response (DOR) data is expected to support a New Drug Application (NDA) for UGN-102, targeting low-grade intermediate-risk non-muscle invasive bladder cancer. The company plans to complete the NDA submission soon, with a potential FDA decision as early as Q1 2025, assuming priority review.
August 13, 2024 | 12:06 pm
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UroGen Pharma's latest DOR data is expected to support an NDA for UGN-102, targeting bladder cancer. The company plans to complete the NDA submission soon, with a potential FDA decision as early as Q1 2025, assuming priority review.
The announcement of the NDA submission for UGN-102 and the potential for an FDA decision as early as Q1 2025 is a significant milestone for UroGen Pharma. This could lead to increased investor confidence and a positive short-term impact on the stock price.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100