Applied Therapeutics, Inc. announced that it completed a meeting with the U.S. Food and Drug Administration (FDA) in the third quarter of 2025. The meeting was held to discuss the potential new drug application (NDA) submission for govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (SORD) Deficiency (CMT-SORD).
The company is currently awaiting the receipt of official meeting minutes from the FDA to determine its next steps. This feedback is crucial for outlining the path forward for a potential submission strategy.
At this time, a definitive path forward regarding a potential submission strategy for regulatory approval, including under the accelerated approval pathway, has not yet been determined. Applied Therapeutics reiterated its commitment to addressing the unmet needs of patients living with CMT-SORD.
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