Travere Therapeutics announced that the U.S. Food and Drug Administration has extended its Prescription Drug User Fee Act (PDUFA) target action date for the supplemental New Drug Application (sNDA) of Filspari in focal segmental glomerulosclerosis (FSGS) to April 13, 2026. This represents a three-month delay from the company’s self-imposed January 13 deadline. The extension follows Travere’s submission of additional data and responses to FDA inquiries intended to further characterize the clinical benefit of Filspari in FSGS patients.

In response to the regulatory delay, Travere’s stock declined sharply, dropping by nearly 15% on the announcement day. Trading volume surged to approximately 20 million shares, compared with an average daily volume of 1.9 million, indicating heightened investor concern over the extended review timeline and its impact on the expected commercial launch schedule for Filspari in FSGS.

Filspari, already approved for IgA nephropathy, would become the first FDA-approved therapy for FSGS if granted the new indication. FSGS is a rare kidney disorder characterized by scarring of the glomeruli, affecting an estimated 20,000 patients in the United States. Analysts estimate peak annual sales of $450 million to $550 million for Filspari in FSGS, underscoring the importance of the sNDA decision for Travere’s growth trajectory.

Travere entered the reporting period with a cash balance of $200 million and minimal debt, providing runway through the FDA decision and potential commercial launch preparations. The delay may push anticipated revenue recognition into 2027, deferring a meaningful impact on the company’s 2026 guidance. Management reiterated confidence in long‐term value creation, citing an 85% gross margin on existing Filspari sales and a disciplined approach to operating expenses.