Applied Thera tanks, as FDA slaps CRL on govorestat NDA

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics (Nasdaq: APLT).

The news comes as a surprise, as just a couple of months ago the FDA confirmed that an Advisory Committee meeting, previously scheduled for October, will no longer be necessary. The news sent Applied’s shares down 16% by close of trading and the stock took a further 77% dive to $1.95 in after-hours activity.

The CRL indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application.