---
schema_version: "secwatch.filing_event.v1"
accession: "0001438533-26-000005"
form_type: "8-K"
ticker: "TVTX"
cik: "0001438533"
company_name: "Travere Therapeutics, Inc."
filed_at: "2026-01-13T23:59:59+00:00"
generated_at: "2026-05-16T10:38:50.858870+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA extends FILSPARI FSGS sNDA PDUFA to April 13, 2026; cites Major Amendment

## Summary
- FDA extended PDUFA target action date to April 13, 2026, after determining supplemental NDA responses constitute a Major Amendment.
- No safety or manufacturing concerns raised; FDA requested additional characterization of FILSPARI's clinical benefit in FSGS.
- If approved, FILSPARI would be the first FDA-approved pharmacologic therapy for focal segmental glomerulosclerosis (FSGS).
- Phase 3 DUPLEX study missed primary eGFR slope endpoint but showed proteinuria reduction and lower end-stage kidney disease rate vs irbesartan.

## SEC filing metadata
- accession: 0001438533-26-000005
- form_type: 8-K
- ticker: TVTX
- cik: 0001438533
- company_name: Travere Therapeutics, Inc.
- filed_at: 2026-01-13T23:59:59+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/1438533/000143853326000005/0001438533-26-000005-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438533/000143853326000005/tvtx-20260113.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438533-26-000005
- JSON: https://secwatch.observer/filing/0001438533-26-000005.json
- Plain text: https://secwatch.observer/filing/0001438533-26-000005.txt

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