08:58 AM EDT, 05/16/2025 (MT Newswires) -- (Updates with previous company statement, recent share movement starting in the fourth paragraph.)

Travere Therapeutics ( TVTX ) said late Thursday the US Food and Drug Administration accepted its supplemental New Drug Application for approval of Filspari to treat focal segmental glomerulosclerosis, a kidney disease.

The drug application submission was based on phase 2 and phase 3 trial results involving both adult and pediatric patients, according to the company.

The FDA assigned a Prescription Drug User Fee Act target action date of Jan. 13, 2026, and signaled it is planning an advisory committee meeting regarding the application, the company added.

The biopharmaceutical company previously said in March it was seeking priority review from the FDA and was expecting a risk evaluation and mitigation strategy modification PDUFA target action date of Aug. 28, 2025.

Shares were over 17% lower in recent premarket activity.