07:47 AM EDT, 09/10/2025 (MT Newswires) -- Travere Therapeutics ( TVTX ) said Wednesday that the US Food and Drug Administration has told the company that an advisory committee is "no longer needed" for the review of Filspari's supplemental New Drug Application in focal segmental glomerulosclerosis.

The company said the application is still being reviewed by the FDA, with a target action date of Jan. 13.

The application is backed by two studies in which Filspari showed "rapid, superior and sustained reductions" in proteinuria compared to irbesartan across adult and pediatric patients, the company said.

Shares of Travere were up as much as 16% in recent Wednesday premarket activity.