According to the Complaint, Applied Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. This class action was filed against the Company and two of its Officers.

The Company’s lead drug candidate, govorestat, is a central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. During the Class Period, Defendants provided investors with material information concerning Applied Therapeutics’ Phase III INSPIRE trial results for govorestat and the drug’s efficacy in treating Galactosemia.

The Complaint alleges that Defendants provided positive statements to investors while, at the same time, disseminating false and materially misleading statements and/or concealing material adverse facts concerning the true state of Applied Therapeutics’ Phase III INSPIRE trial; notably, electronic data capture issues and a dosing error in the dose-escalation phase of the study. The Complaint further alleges that such statements absent these material facts caused Plaintiff and other shareholders to purchase Applied Therapeutics’ securities at artificially inflated prices.

On March 11, 2025, the Court issued an Order consolidating cases and appointing Lead Plaintiff and Counsel. All future docketing was ordered to be done in the Lead Case 24-CV-09715.

Lead Plaintiff filed a Consolidated Amended Complaint on May 2, 2025. On June 13, Lead Plaintiff filed a second Consolidated Amended Complaint.