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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

After being FDA approved for only three years, Novo Nordisk, the parent company of Wegovy and Ozempic, has released a statement that they are seeing at least 25,000 new U.S