---
schema_version: "secwatch.filing_event.v1"
accession: "0001438533-25-000049"
form_type: "8-K"
ticker: "TVTX"
cik: "0001438533"
company_name: "Travere Therapeutics, Inc."
filed_at: "2025-09-10T23:59:59+00:00"
generated_at: "2026-05-17T06:58:47.891568+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA says no advisory committee needed for FILSPARI sNDA in FSGS; PDUFA Jan 13, 2026

## Summary
- FDA informed Travere that an advisory committee is no longer needed for the FILSPARI (sparsentan) sNDA for FSGS.
- The sNDA remains under review with a PDUFA target action date of January 13, 2026.
- If approved, FILSPARI would be the first medication indicated for FSGS, a rare kidney disorder.
- sNDA is supported by Phase 3 DUPLEX and Phase 2 DUET studies showing superior proteinuria reduction vs. irbesartan.
- FILSPARI is already fully approved for IgA nephropathy in the US and EU.

## SEC filing metadata
- accession: 0001438533-25-000049
- form_type: 8-K
- ticker: TVTX
- cik: 0001438533
- company_name: Travere Therapeutics, Inc.
- filed_at: 2025-09-10T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438533/000143853325000049/0001438533-25-000049-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438533/000143853325000049/tvtx-20250910.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438533-25-000049
- JSON: https://secwatch.observer/filing/0001438533-25-000049.json
- Plain text: https://secwatch.observer/filing/0001438533-25-000049.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.