UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC
UroGen announced FDA acceptance of the NDA for UGN-103, an investigational intravesical mitomycin for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, with a PDUFA target action date of June 14, 2027. The filing is backed by the ongoing Phase 3 UTOPIA trial, in which UGN-103 produced a 77.8% complete response rate at three months and a 94.5% estimated six-month event-free probability among responders — results consistent with the pivotal ENVISION trial of ZUSDURI. UGN-103 builds on UroGen's approved ZUSDURI using its RTGel technology with a streamlined manufacturing process, licensed from medac in January 2024, with U.S.
Key figures
- Drug Name
- UGN-103 (mitomycin) for intravesical solution
- Phase Of Trial
- Phase 3
- Pdufa date
- June 14, 2027
- Ip expiration
- July 2044
- Cr rate 3 month
- 77.8%
- Utopia patients
- 99
- Event free probability 6 month
- 94.5%
- Us recurrent lg ir nmibc patients
- 59000
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