11:32 AM EDT, 03/28/2024 (MT Newswires) -- PTC Therapeutics ( PTCT ) said Thursday it is seeking a marketing authorization from the European Medicines Agency for sepiapterin as a treatment for phenylketonuria, or PKU, a rare metabolic disease that affects the brain.

The company said the filing of a marketing authorization application with EMA is the first in a series of global submissions following positive data from clinical trials of sepiapterin.

PTC said it expects to submit a New Drug Application to the US Food and Drug Administration no later than Q3.

Regulatory submissions are also planned for this year in other countries, including Brazil and Japan, where PTC has existing rare disease commercial infrastructure, it said.