other material
confidence high
sentiment neutral
materiality 0.85
Travere's FILSPARI misses eGFR total slope endpoint but achieves chronic slope significance in IgAN
Travere Therapeutics, Inc.
- eGFR total slope difference vs irbesartan 1.0 mL/min/1.73m2 per year, p=0.058 (missed statistical significance).
- eGFR chronic slope difference 1.1 mL/min/1.73m2 per year, p=0.037 (statistically significant).
- Company to submit sNDA for full FDA approval of FILSPARI in IgAN in first half of 2024.
- EU CMA decision for sparsentan in IgAN expected from CHMP around end of 2023.