05:22 PM EDT, 10/14/2024 (MT Newswires) -- PTC Therapeutics ( PTCT ) said Monday the US Food and Drug Administration has set a target regulatory action date of July 29 to review its sepiapterin to treat pediatric and adult patients with phenylketonuria.

The company said late Monday that the treatment is for all age groups and the full spectrum of disease subtypes. The review deadline is "consistent" with a standard timeline.

PTC said the sepiapterin New Drug Application includes the results from a phase 3 trial and data from an ongoing study, which provides evidence of "the durability of effect of sepiapterin and the ability of patients to liberalize their diet and still maintain control of phenylalanine levels."

Phenylketonuria is a disorder that can cause decreased metabolism of the amino acid phenylalanine that can lead to intellectual disability, seizures, behavioral problems, and mental disorders.

PTC shares were up 1.5% in after-hours activity.

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