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.

Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, causing its shares to crater Friday.

Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, prompting a downgrade by RBC Capital. Read more here.

Applied Therapeutics' stock plummeted 75 percent after the Food and Drug Administration (FDA) rejected approving govorestat as a treatment for galactosemia.