Travere Successful pre-NDA Meeting for FILSPARI, More Regulatory, Corporate Updates

 After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgAN to full approval

Following engagement with the FDA on the two-year results from the Phase 3 DUPLEX Study in FSGS, Company conducting additional analyses of FSGS data and plans to re-engage FDA in 2024

Company is implementing a strategic reorganization to further focus near-term resources on ongoing FILSPARI launch in IgAN and advancement of pegtibatinase in classical HCU, extending expected cash runway into 2028

https://www.globenewswire.com/news-release/2023/12/04/2790450/0/en/Travere-Completes-Successful-pre-NDA-Meeting-for-FILSPARI-in-IgAN-Provides-Regulatory-Updates-for-both-IgAN-and-FSGS.html