---
schema_version: "secwatch.filing_event.v1"
accession: "0001438533-25-000032"
form_type: "8-K"
ticker: "TVTX"
cik: "0001438533"
company_name: "Travere Therapeutics, Inc."
filed_at: "2025-05-15T23:59:59+00:00"
generated_at: "2026-05-21T04:48:17.465560+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Travere's sNDA for FILSPARI in FSGS; PDUFA Jan 13, 2026

## Summary
- FDA accepted sNDA for traditional approval of FILSPARI (sparsentan) to treat focal segmental glomerulosclerosis (FSGS).
- PDUFA target action date is January 13, 2026; FDA plans an advisory committee meeting.
- If approved, FILSPARI would be first FDA-approved drug for FSGS, affecting over 40,000 U.S. patients.
- sNDA supported by Phase 3 DUPLEX (met interim proteinuria endpoint, missed primary eGFR slope) and Phase 2 DUET studies.
- No approved pharmacologic treatment currently exists for FSGS.

## SEC filing metadata
- accession: 0001438533-25-000032
- form_type: 8-K
- ticker: TVTX
- cik: 0001438533
- company_name: Travere Therapeutics, Inc.
- filed_at: 2025-05-15T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438533/000143853325000032/0001438533-25-000032-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438533/000143853325000032/tvtx-20250515.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438533-25-000032
- JSON: https://secwatch.observer/filing/0001438533-25-000032.json
- Plain text: https://secwatch.observer/filing/0001438533-25-000032.txt

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