---
schema_version: "secwatch.filing_event.v1"
accession: "0001438533-23-000002"
form_type: "8-K"
ticker: "TVTX"
cik: "0001438533"
company_name: "Travere Therapeutics, Inc."
filed_at: "2023-02-17T23:59:59+00:00"
generated_at: "2026-06-19T07:55:11.394892+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA grants accelerated approval to Travere's FILSPARI for IgA nephropathy

## Summary
- FDA approved FILSPARI (sparsentan) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid progression; continued approval contingent on confirmatory data.
- FILSPARI showed 45% mean reduction in proteinuria vs 15% for irbesartan in post-hoc sensitivity analysis (label data).
- Travere expects to pay $23M milestone to Ligand and BMS in Q1 2023 due to approval.
- Topline confirmatory endpoint results from PROTECT Study expected Q4 2023; DUPLEX FSGS results expected Q2 2023.
- FILSPARI to be available week of Feb 27, 2023; estimated addressable US patients 30,000-50,000.

## SEC filing metadata
- accession: 0001438533-23-000002
- form_type: 8-K
- ticker: TVTX
- cik: 0001438533
- company_name: Travere Therapeutics, Inc.
- filed_at: 2023-02-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1438533/000143853323000002/0001438533-23-000002-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1438533/000143853323000002/tvtx-20230217.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001438533-23-000002
- JSON: https://secwatch.observer/filing/0001438533-23-000002.json
- Plain text: https://secwatch.observer/filing/0001438533-23-000002.txt

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