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Applied Therapeutics, Inc. (NASDAQ: APLT) (the Company), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced that the Company completed a meeting with the U.S. Food and Drug Administration (FDA) to discuss the potential new drug application (NDA) submission for govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (SORD) Deficiency (CMT-SORD) 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.
About Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD)
CMT-SORD is a rare, progressive, debilitating hereditary neuropathy that affects peripheral nerves and motor neurons. CMT-SORD is one of the most common forms of recessive hereditary neuropathy and affects approximately 3,300 patients in the U.S. and 4,000 patients in the EU. The disease is caused by a lack of the enzyme sorbitol dehydrogenase, responsible for the metabolism of sorbitol, which causes sorbitol to accumulate at high levels in blood and tissues. Intracellular sorbitol accumulation is implicated in significant disability, loss of sensory function, neuromuscular dysfunction, and decreased mobility.
Posted In: APLT
