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Dose:15.00 mg

28 note to investors, William Blair analysts wrote that Applied Therapeutics “suspects” the CRL “was related to the efficacy package as opposed to [chemistry, manufacturing and controls] or safety.” Results from the Phase III ACTION-Galactosemia Kids study, unveiled in April 2023, showed that govorestat fell short of its primary efficacy endpoint, a composite of four clinical measures designed to assess various domains of galactosemia symptoms