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Filspari (sparsentan) PDUFA Date (Travere Therapeutics)

FDA PDUFA decision date for Filspari (sparsentan) is April 13, 2026. Developed by Travere Therapeutics. Indication: Focal segmental glomerulosclerosis (FSGS). Current status: Approved.

Indication

Focal segmental glomerulosclerosis (FSGS)

Notes

Extended from Jan 13, 2026. Confirmatory endpoint data for accelerated approval conversion.

Regulatory details

  • Company: Travere Therapeutics
  • Therapeutic area: Rare Disease / Nephrology
  • Application type: sNDA
  • Review type: Standard
  • PDUFA date: 2026-04-13
  • Outcome: Approved
Filspari (sparsentan) PDUFA Date — Travere Therapeutics