Travere Therapeutics, Inc. (TVTX) yesterday announced that the U.S. FDA has extended the review period for the supplemental New Drug Application of FILSPARI in focal segmental glomerulosclerosis.
The extension follows the agency's request for additional time to evaluate data submitted in support of the application, delaying a potential approval decision. The new PDUFA target action date is set to April 13, 2026. The decision was originally slated for January 13, 2026.
Focal segmental glomerulosclerosis (FSGS) is a rare and serious kidney disorder characterized by scarring in the glomeruli, often leading to progressive kidney failure and, in many cases, end-stage renal disease requiring dialysis or transplantation. Current treatment options remain limited, which makes the FDA's review of FILSPARI particularly significant for patients and physicians seeking new therapies.
FILSPARI (sparsentan) is a dual endothelin angiotensin receptor antagonist designed to reduce proteinuria and slow kidney disease progression. The drug is already approved in the United States for IgA nephropathy, a rare kidney disorder, and is marketed with a Risk Evaluation and Mitigation Strategy program.
In 2025, the FDA approved modifications to the REMS program to expand patient access in IgA nephropathy, reflecting growing confidence in the therapy's safety profile.
Travere expects the FDA to issue a decision following the extended review period, and if approved, FILSPARI would become the first dual endothelin angiotensin receptor antagonist available for FSGS, potentially establishing a new standard of care.
Ligand Pharmaceuticals Inc. (LGND) has a licensing agreement with Travere for Filspari under which Ligand receives a 9% royalty on global net product sales.
Filspari generated net product sales of $132 million in full-year 2024 and is expected to deliver approximately $322 million in full-year 2025.
TVTX has traded between $12.91 and $42.13 over the past year. The stock closed yesterday's trading at $29.11, down 14.62% and fell further in the pre-market trading to $28.22, down 3.06%.
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