"This NDA submission is an important step in bringing this therapy to children and adults living with PKU in the U.S.," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "The robust sepiapterin clinical trial data, including Phe tolerance results, support the potential of sepiapterin to meet the persistent unmet medical need for the large number of children and adults with PKU." The European marketing authorization application is currently under review and the marketing authorization ...