Robbins LLP is Investigating Allegations that Applied Therapeutics, Inc. (APLT) Misled Investors Regarding its Lead Drug Candidate

Robbins LLP announces that a class action was filed on behalf of all investors who purchased or otherwise acquired Applied Therapeutics, Inc. (NASDAQ: APLT) securities between January 3, 2024 and December 2, 2024. Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases.

The Allegations

According to the complaint, during the class period, defendants misled investors regarding the Company’s Phase III INSPIRE trial results for govorestat and the drug’s efficacy in treating Galactosemia. Defendants’ statements included, among other things, confidence in the Company’s New Drug Application (NDA) to the FDA for govorestat, submission of a Marketing Authorization Authority to the European Medicines Agency for the same, positive clinical outcomes data from the Phase 3 registrational ACTION-Galactosemia Kids study in children age 2-17 with Galactosemia, the Phase 1/2 ACTION-Galactosemia study in adult patients with Galactosemia, and preclinical data as well as positive interim trial results from the Phase III INSPIRE trial.

The complaint alleges that Applied Therapeutics issued a press release on November 27, 2024, announcing it had received a Complete Response Letter (CRL) for the NDA for govorestat due to deficiencies in the clinical application. On this news, Applied Therapeutics’ common stock fell to $8.57 per share on November 27, 2024, before falling further to $2.03 on November 29, 2024, and $1.75 per share on December 2, 2024, a total decline of more than 80%.

Then, on December 2, 2024, Applied Therapeutics disclosed it received a “warning letter” from the FDA referring to the clinical trial issues underlying the CRL. Applied Therapeutics' common stock fell again on this news.

What Now: You may be eligible to participate in the class action against Applied Therapeutics, Inc. Shareholders who want to serve as lead plaintiff for the class must submit their application to the court by February 18, 2025. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.