Travere Therapeutics, Inc. (TVTX) — Current Report

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Earlier Current Report filings

Filed: 2026-01-13
  • The FDA has extended the review timeline for Travere Therapeutics' supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), with a new Prescription Drug User Fee Act (PDUFA) target action date of April 13, 2026.
  • If approved, FILSPARI would be the first medication indicated for FSGS, a rare and serious kidney disorder that can lead to progressive kidney function loss and kidney failure.
  • The extension follows the recent submission of responses requested by the FDA to further characterize the clinical benefit of FILSPARI, and no additional information relating to the safety or manufacturing of FILSPARI has been requested.

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