---
schema_version: "secwatch.filing_event.v1"
accession: "0001438533-25-000012"
form_type: "8-K"
ticker: "TVTX"
cik: "0001438533"
company_name: "Travere Therapeutics, Inc."
filed_at: "2025-03-17T23:59:59+00:00"
generated_at: "2026-05-24T15:25:53.147344+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Travere submits sNDA to FDA seeking priority review for FILSPARI in FSGS

## Summary
- Submitted sNDA on March 17, 2025 seeking priority review for traditional approval of FILSPARI (sparsentan) for FSGS.
- Supported by Phase 3 DUPLEX study (interim FPRE endpoint met; primary eGFR slope missed) and Phase 2 DUET study (met primary endpoint).
- FDA has 60 days to decide on acceptance; company expects notice in Q2 2025.
- If approved, FILSPARI would be first FDA-approved therapy for FSGS, affecting >40,000 US patients.
- No currently approved pharmacologic therapies for FSGS.

## SEC filing metadata
- accession: 0001438533-25-000012
- form_type: 8-K
- ticker: TVTX
- cik: 0001438533
- company_name: Travere Therapeutics, Inc.
- filed_at: 2025-03-17T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438533/000143853325000012/0001438533-25-000012-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438533/000143853325000012/tvtx-20250317.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438533-25-000012
- JSON: https://secwatch.observer/filing/0001438533-25-000012.json
- Plain text: https://secwatch.observer/filing/0001438533-25-000012.txt

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