Applied Therapeutics Completes Late-Cycle Meeting With FDA Regarding NDA Review Of Govorestat

(RTTNews) - Applied Therapeutics (APLT) announced an update on the ongoing New Drug Application review of govorestat for the treatment of Classic Galactosemia. The PDUFA target action date remains on track for November 28, 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 FDA has communicated that an Advisory Committee meeting would no longer be required, which was previously tentatively scheduled for October 9, 2024.

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