27 November 2024 - Applied Therapeutics today announced that the US FDA has issued a complete response letter for the new drug application for govorestat, a novel, central nervous system penetrant aldose reductase inhibitor for the treatment of classic galactosaemia.

The complete response letter indicates that the FDA completed its review of the application and determined that it is unable to approve the new drug application in its current form, citing deficiencies in the clinical application.

Read Applied Therapeutics press release