Travere Therapeutics Provides Regulatory Updates On Its Development Programs

PDUFA target action date for NDA for sparsentan in IgAN on-track for November 17, 2022   Company to utilize traditional approval process for sparsentan in FSGS following completion of the pivotal Phase 3 DUPLEX

PDUFA target action date for NDA for sparsentan in IgAN on-track for November 17, 2022

 

Company to utilize traditional approval process for sparsentan in FSGS following completion of the pivotal Phase 3 DUPLEX Study in 2023

Company and its partner Vifor Pharma applying for conditional marketing authorization of sparsentan for IgAN in Europe; review decision expected in second half of 2023

Pegtibatinase granted Breakthrough Therapy Designation by FDA

Company to host conference call and webcast tomorrow at 8:00 a.m. ET

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