02:17 PM EDT, 09/18/2024 (MT Newswires) -- Applied Therapeutics ( APLT ) shares were up nearly 65% in recent Wednesday trading after the company reported an update on the ongoing New Drug Application review by the US Food and Drug Administration for Classic Galactosemia experimental drug govorestat.

The FDA said that a meeting of the advisory committee would not be needed, which was initially planned for Oct. 9, adding that the priority review of the application is progressing as planned, with further alignment on post-marketing requirements expected in October, according to the company.

The Prescription Drug User Fee Act target action date for the FDA's final decision on govorestat remains on track for Nov. 28, it added.

Price: 7.66, Change: +3.01, Percent Change: +64.73