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Will FDA’s Extended FILSPARI FSGS Review Timeline Change Travere Therapeutics’ (TVTX) Narrative

Will FDA’s Extended FILSPARI FSGS Review Timeline Change Travere Therapeutics’ (TVTX) Narrative

  • Travere Therapeutics recently reported that the FDA has extended its review of the supplemental New Drug Application for FILSPARI in focal segmental glomerulosclerosis (FSGS), setting a new PDUFA action date of April 13, 2026, after the company submitted additional data to better characterize clinical benefit.
  • The extension keeps FILSPARI under active regulatory review for what could become the first approved pharmacologic treatment for FSGS, a rare kidney disorder with no current FDA‑approved medicines and significant unmet medical need.
  • We will now examine how the FDA’s extended review timeline for FILSPARI in FSGS influences Travere Therapeutics’ longer‑term investment narrative.

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