PTC Therapeutics Reports Filing Acceptance For Sepiapterin - Quick Facts

(RTTNews) - PTC Therapeutics (PTCT) announced the FDA has accepted for filing the New Drug Application of sepiapterin for the treatment of pediatric and adult patients living with phenylketonuria. A PDUFA target action date is expected to be provided in the Day 74 Letter. The sepiapterin NDA is based on the results from the phase 3 APHENITY trial.

Matthew Klein, CEO of PTC Therapeutics, said: "The clinical trial data, including the evidence of enabling diet liberalization, support that sepiapterin can provide significant benefit to PKU patients, helping to meet the persistent, significant unmet need in this community."

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