Travere Therapeutics Reports Record FILSPARI Demand, Provides FSGS Update

Company highlights strong Q4 and full-year 2025 results, including progress on key pipeline programs.

Published on Feb. 27, 2026

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Travere Therapeutics (NASDAQ:TVTX) reported record demand for its approved medicine FILSPARI in IgA nephropathy (IgAN), provided an update on the FDA's review timeline for a potential focal segmental glomerulosclerosis (FSGS) indication, and discussed the restart of global site activation for its Phase 3 pegtibatinase study in classical homocystinuria (HCU) during its Q4 and full-year 2025 earnings call.

Why it matters

Travere's performance highlights the growing demand for innovative treatments in rare kidney diseases, as the company continues to advance its pipeline and navigate the regulatory landscape. The updates on FILSPARI, FSGS, and pegtibatinase demonstrate Travere's commitment to addressing unmet needs for patients with limited treatment options.

The details

In IgAN, Travere reported record Q4 demand of 908 new patient starts for FILSPARI, driven by growing physician confidence in the drug's differentiated profile as a once-daily oral, non-immunosuppressive therapy. The company also provided an update on the FDA's review timeline for a potential FSGS indication, noting that the agency had requested additional information, resulting in a new PDUFA target action date of April 13, 2026. Travere remains confident in FILSPARI's FSGS profile based on the strength and consistency of results from previous studies. Beyond FILSPARI, the company discussed the restart of global site activation for its Phase 3 HARMONY study of pegtibatinase in classical HCU, a serious genetic metabolic disorder.

  • Travere received notification in January 2026 that the FSGS sNDA filing included a major amendment, resulting in a new PDUFA target action date of April 13, 2026.
  • Travere reported record Q4 2025 demand of 908 new patient starts for FILSPARI.

The players

Travere Therapeutics

A biopharmaceutical company headquartered in San Diego, California, dedicated to the development and commercialization of therapies for rare kidney and genetic disorders.

FILSPARI

Travere's approved medicine for the treatment of IgA nephropathy, a rare kidney disease.

U.S. Food and Drug Administration (FDA)

The regulatory agency responsible for reviewing Travere's supplemental new drug application (sNDA) for a potential FSGS indication for FILSPARI.

Pegtibatinase

Travere's investigational therapy for the treatment of classical homocystinuria (HCU), a serious genetic metabolic disorder.

HARMONY

Travere's pivotal Phase 3 study evaluating pegtibatinase in classical HCU.

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