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PTC Therapeutics submits sepiapterin NDA to U.S. FDA

PTC Therapeutics submits sepiapterin NDA to U.S. FDA

PTC Therapeutics announced the submission of the sepiapterin NDA to the U.S. FDA. The NDA submission is for the treatment of pediatric and adult patients with phenylketonuria, including the full spectrum of ages and disease subtypes. The European marketing authorization application is currently under review and the marketing authorization applications for Japan and Brazil are expected to be submitted later in 2024.

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