PTC Therapeutics Says Potential Phenylketonuria Drug Receives EU Panel's Positive Opinion

MT Newswires Live

2025/04/25

PTC Therapeutics (PTCT) said Friday that its marketing authorization application for Sephience for the treatment of phenylketonuria has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use.

The CHMP opinion recommends a label that includes all ages and disease severities, the company said, adding it expects the European Commission to take a decision in about two months.

The company said launch planning in Europe is ongoing, with Germany as a priority market.

Sephience, or sepiapterin, is also under review in the US for phenylketonuria, an inherited metabolic disease that affects the brain, PTC said.

Price: 48.78, Change: -0.77, Percent Change: -1.55

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