02:11 PM EST, 01/13/2026 (MT Newswires) -- Travere Therapeutics ( TVTX ) said Tuesday the US Food and Drug Administration has extended its review of the supplemental new drug application for Filspari, or sparsentan, in focal segmental glomerulosclerosis, a rare kidney disorder.

The regulator's new target action date is April 13, the company said, adding that the delay follows additional data it submitted at the FDA's request to further explain Filspari's clinical benefit.

The FDA classified the additional responses as a major amendment to the application and extended the action date. The regulator did not request any new safety or manufacturing information, the company said.

Shares of Travere Therapeutics ( TVTX ), halted earlier Tuesday, dropped 33% in recent trading.

Price: 22.71, Change: -11.39, Percent Change: -33.40