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.
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Travere Therapeutics: Restructuring Away From Disaster