07:48 AM EDT, 06/23/2025 (MT Newswires) -- PTC Therapeutics ( PTCT ) said Monday the European Commission has granted marketing authorization for Sephience to treat children and adults with phenylketonuria.

The approval is based on results from the phase 3 APHENITY trial and the APHENITY long-term extension study, the company said. The marketing authorization applies to all 27 European Union member states as well as Iceland, Norway and Liechtenstein.

The European launch of Sephience will take place in Germany in the first half of July, the company said.

PTC Therapeutics ( PTCT ) added its New Drug Application for Sephience remains on schedule for its US Food and Drug Administration target action date of July 29, while approval applications in other countries including Japan and Brazil are still being reviewed.