Travere Therapeutics drops after FDA request to characterize FILSPARI benefit

Travere Therapeutics (TVTX) is down nearly 33% in premarket trading after the company said Monday that its PDUFA target action date for its sNDA seeking full approval for FILSPARI in FSGS is January 13, 2026. The company recently received additional information requests from the FDA to further characterize the clinical benefit of FILSPARI and recently submitted responses to address the agency’s questions, which are currently under review by the agency. If approved, FILSPARI would be the first and only medication approved for FSGS, a rare kidney disorder and a leading cause of kidney failure, Travere added.