UroGen Announces FDA Acceptance Of Its New Drug Application For UGN-102 For Intravesical Solution
Portfolio Pulse from Benzinga Newsdesk
UroGen Pharma Ltd. announced that the FDA has accepted its New Drug Application for UGN-102, a potential treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. The PDUFA goal date is set for June 13, 2025.
October 15, 2024 | 8:32 pm
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UroGen Pharma's NDA for UGN-102 has been accepted by the FDA, with a PDUFA date set for June 13, 2025. If approved, it will be the first treatment for LG-IR-NMIBC, potentially boosting the company's market position.
The acceptance of the NDA by the FDA is a significant milestone for UroGen Pharma, indicating progress towards potential approval. If UGN-102 is approved, it would be the first treatment for LG-IR-NMIBC, which could lead to increased market share and revenue for the company. The PDUFA date provides a timeline for investors to anticipate potential approval.
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