UroGen Says FDA Agrees to New Drug Application for UGN-103 Based on Phase 3 Data

MT Newswires Live

2025/11/06

UroGen Pharma (URGN) said Thursday that the US Food and Drug Administration has agreed that the preliminary complete response rate and durability results from an ongoing phase 3 trial of UGN-103 in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer can support the submission of a new drug application.

Initial results from the study showed a 77.8% three-month complete response rate, which is consistent with the 79.6% three-month complete response rate after treatment with UroGen's FDA-approved bladder cancer drug Zusduri in a pivotal trial, according to a statement.

The company said it is preparing for an NDA submission in 2026.

UroGen said UGN-103 will have a shorter manufacturing process and simplified reconstitution procedure compared with Zusduri.

Shares of UroGen were up more than 3% in recent trading Thursday.

Price: 19.92, Change: +0.61, Percent Change: +3.16

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