Applied Therapeutics (APLT) announced that the Company completed a meeting with the U.S. Food and Drug Administration to discuss the potential new drug application submission for govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency in the third quarter of 2025. The Company is awaiting the receipt of official meeting minutes from the FDA in order to determine next steps. At this time, a path forward regarding a potential submission strategy for regulatory approval, including under the accelerated approval pathway, has not been determined. The Company remains committed to addressing the unmet needs of patients living with CMT-SORD.
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