The FDA decision on Travere Therapeutics Inc.’s (TVTX) supplemental New Drug Application seeking traditional approval of Filspari for the treatment of focal segmental glomerulosclerosis is expected on January 13, 2026.Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder characterized by proteinuria, in which protein leaks into the urine due to a breakdown in the kidney’s normal filtration mechanism. The condition affects an estimated 40,000 patients in the United States, with a similar prevalence in Europe. The disorder is marked by progressive scarring of the kidney and often leads to end-stage kidney disease (ESKD). In May 2021, the FDA declined Travere’s request for accelerated approval of Filspari in FSGS, determining that interim data from a phase 3 trial, dubbed DUPLEX, were insufficient to support such approval at that time. Travere subsequently completed the DUPLEX Study, where Filspari demonstrated rapid, superior, and sustained reductions in proteinuria compared with the maximum labeled dose of the approved diabetic nephropathy drug Irbesartan in children and adults with FSGS. The drug is already approved in the U.S. to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression. Net product sales of Filspari were $132 million in the full year of 2024, and $218.7 million in the first nine months of 2025. Ligand Pharmaceuticals Inc. (LGND) has a licensing agreement with Travere for Filspari under which Ligand receives a 9% royalty on global net product sales.TVTX closed Monday’s (Dec.29, 2025) trading at $38.88, down 1.92%.