PTC Therapeutics: EMA To Review Sepiapterin MAA For PKU

(RTTNews) - PTC Therapeutics, Inc. (PTCT) announced that the sepiapterin MAA for PKU has been validated and accepted for review by the EMA. The sepiapterin MAA includes data from the phase 3 APHENITY trial.

PTC expects to submit the sepiapterin NDA to the FDA no later than the third quarter of 2024. The company noted that submissions are planned in a number of additional countries in 2024 including Brazil and Japan.

Matthew Klein, Chief Executive Officer, said: "The European submission is the first of several global submissions planned in 2024."

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