04:38 AM EDT, 07/29/2025 (MT Newswires) -- PTC Therapeutics ( PTCT ) said late Monday that the US Food and Drug Administration has approved its Sephience drug to treat phenylketonuria in both children and adults.

The drug is approved for hyperphenylalaninemia in patients as young as one month of age with sepiapterin-responsive phenylketonuria.

Phenylketonuria is a rare, inherited metabolic disease that impacts the brain.

The company's shares were up 10% in recent premarket activity Tuesday.