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