FDA Reaffirms Proteinuria Endpoint for FSGS: Positive Signal for Travere Therapeutics
FDA confirms proteinuria reduction as valid FSGS approval endpoint in Dimerix feedback, boosting confidence in Travere Therapeutics' upcoming Filspari decision.
FDA confirms proteinuria reduction as valid FSGS approval endpoint in Dimerix feedback, boosting confidence in Travere Therapeutics' upcoming Filspari decision.
Travere Therapeutics shares jumped 15% after reporting a strong Q3 profit of $25.7M, driven by surging FILSPARI sales and better-than-expected earnings. Citi raised its price target to $48, citing optimism for FDA approval in early 2026.
FILSPARI (sparsentan) for rare kidney disease FSGS is close to FDA approval, with no advisory committee needed! It's the 1st potential treatment, showing strong trial results by reducing protein in urine and lowering kidney failure risk. PDUFA date: Jan 13, 2026.