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TVTX - Travere Therapeutics: Restructuring Away From Disaster
Travere Therapeutics Inc Com
2024-01-29 22:33:19 ET
Summary
Travere Therapeutics faces challenges following disappointing data from its PROTECT trial in September 2023.
The FDA granted accelerated approval for Travere's FILSPARI, but its continued approval is contingent upon confirmation of clinical benefit in the ongoing PROTECT Study.
Accelerated approval allows the FDA to approve a drug based on surrogate endpoints, but it requires subsequent validation in a confirmatory study.