APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA

Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application (NDA) seeking approval for APLT’s lead candidate, govorestat, to treat classic galactosemia. The CRL stated that the FDA has reviewed the application and cannot approve the NDA in its current form due to deficiencies in the clinical study results submitted in support of the application.Applied Therapeutics is evaluating the FDA's feedback. It intends to promptly request a meeting to di ...