Applied Therapeutics (APLT) said Monday that a path forward for its new drug application for govorestat to treat Charcot-Marie-Tooth Sorbitol Dehydrogenase deficiency has not been determined.
The company said it completed a meeting with the US Food and Drug Administration to discuss the potential submission in Q3.
Applied Therapeutics said it is waiting for the official meeting minutes from the FDA to decide on the next steps.
Charcot-Marie-Tooth Sorbitol Dehydrogenase deficiency is a genetic metabolic disease.
Shares of Applied Therapeutics were down more than 60% in recent Monday premarket activity.
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