Travere Therapeutics, Inc. 8-K

What Happened
Travere Therapeutics (TVTX) filed an 8‑K on January 13, 2026 announcing that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for its supplemental New Drug Application (sNDA) for FILSPARI (sparsentan) in focal segmental glomerulosclerosis (FSGS) to April 13, 2026. The extension follows Travere’s recent submission of FDA‑requested responses that the agency classified as a Major Amendment (MA). The company said no additional safety or manufacturing information was requested.

Key Details

• Filing date: January 13, 2026; new PDUFA (target action) date: April 13, 2026.
• FDA classified Travere’s recent responses as a Major Amendment, which triggered the review extension.
• FILSPARI is already FDA- and EMA‑approved for slowing kidney decline in adults with IgA nephropathy, but it is not yet approved for FSGS.
• Clinical background: Phase 3 DUPLEX (largest interventional FSGS study) met a 36‑week proteinuria partial remission endpoint but did not meet the 108‑week eGFR slope primary endpoint; two‑year DUPLEX results published in NEJM showed meaningful proteinuria reduction, higher partial/complete remission rates, and lower end‑stage kidney disease versus irbesartan. Phase 2 DUET met its primary endpoint (>2× reduction in proteinuria vs irbesartan). Trials reported consistent safety with no drug‑induced liver injury or fluid overload.

Why It Matters
The FDA extension delays a regulatory decision on FILSPARI for FSGS to mid‑April 2026, pushing out the timeline for potential label expansion and any associated commercial opportunity. If approved, FILSPARI would be the first FDA‑approved drug indicated specifically for FSGS, a rare proteinuric kidney disease affecting an estimated >40,000 U.S. patients. Investors should note the company’s statement that the extension resulted from supplemental data requests (a Major Amendment) and that FDA did not request additional safety or manufacturing information; however, there is no guarantee of approval and timing/outcome remain uncertain.