Applied Therapeutics Inc (APLT)

[tw0122]

.29.  Regulatory UpdateAs previously announced, the Company completed a Type C meeting with the United States Food and Drug Administration (FDA) regarding govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (SORD) Deficiency (CMT-SORD) in the third quarter of 2025. The Company is evaluating the official Type C meeting minutes and post-meeting written correspondence and expects to submit a request for an additional Type C meeting with the FDA with the intent of further discussing a potential Phase 3 trial design.Additionally, the Company recently accepted written feedback from the FDA in connection with its planned meeting on the body of govorestat data submitted by the Company for Classic Galactosemia. The Company is evaluating the feedback with its advisors as it assesses next steps for the development of govorestat for the treatment of Classic Galactosemia. The Company may pursue additional discussions with the FDA regarding a potential Phase 3 trial design at a later date.About Applied TherapeuticsApplied Therapeutics is a clinical-stage bioph