Applied Therapeutics provides update on ongoing NDA review of govorestat

Applied Therapeutics announced an update on the ongoing New Drug Application, NDA, review of govorestat for the treatment of Classic Galactosemia. The Company recently completed its late-cycle review meeting with the United States Food and Drug Administration, FDA. The FDA communicated that an Advisory Committee meeting would no longer be required, which was previously tentatively scheduled for October 9, 2024. The FDA informed the Company that the Priority Review of the NDA is continuing as planned with alignment on post-marketing requirements expected in October 2024. The previously announced Prescription Drug User Fee Act, PDUFA, target action date remains on track for November 28, 2024.