Travere Therapeutics, Inc.

We are a biopharmaceutical company headquartered in San Diego, California, focused on identifying, developing, and delivering therapies for people with rare kidney and metabolic diseases. Our approach involves advancing our pipeline with multiple late-stage clinical programs targeting rare diseases with significant unmet medical needs. In September 2024, the U.S. Food and Drug Administration ("FDA") granted full approval to our lead development program, FILSPARI (sparsentan), indicated to slow kidney function decline in adults with primary Immunoglobulin A nephropathy ("IgAN") who are at risk of disease progression. IgAN is a rare progressive kidney disease and the most common type of primary glomerulonephritis worldwide. FILSPARI received accelerated approval for IgAN in February 2023 based on the surrogate marker of proteinuria. Full approval was based on positive long-term confirmatory results from the PROTECT Study, showing FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. Sparsentan is also in late-stage development for focal segmental glomerulosclerosis ("FSGS"), a rare kidney disease and leading cause of kidney failure with no approved treatment options. In February 2025, we completed a Type C meeting with the FDA, and in March 2025, we submitted an sNDA to the FDA seeking traditional approval of FILSPARI for FSGS. In May 2025, the FDA accepted the sNDA, assigned a PDUFA target action date of January 13, 2026, and initially indicated a plan for an advisory committee meeting. In September 2025, the FDA informed us an advisory committee meeting was no longer needed. In January 2026, the FDA extended the review timeline for the sNDA, with a new PDUFA target action date of April 13, 2026, following the submission of responses requested by the FDA to further characterize the clinical benefit of FILSPARI. The FDA determined these responses constituted a Major Amendment to the sNDA.