Investigation of Applied Therapeutics, Inc

Applied Therapeutics, Inc. (APLT) Holds Submission of New Drug Application for AT-007

Applied Therapeutics Inc., a clinical-stage biopharmaceutical company, develops novel products to target cardiovascular disease, Galactosemia, and diabetic complications. Its lead product candidate is AT-007 for the treatment of Galactosemia, sorbitol dehydrogenase deficiency, and phosphomannomutase enzyme-CDG.

On January 3, 2022, Applied Therapeutics issued a press release “provid[ing] a regulatory update on the AT-007 Galactosemia program.”  In the press release, Applied Therapeutics announced that “[f]ollowing discussions with the FDA at the end of the year, the Company has decided to hold on submitting an NDA for AT-007 for treatment of Galactosemia pending additional discussions with the agency.  Although the Galactosemia program had previously been discussed in the context of an NDA for Accelerated Approval based on reduction in galactitol, the FDA has now indicated that clinical outcomes data will likely be required for approval.”  On this news, Applied Therapeutics’ stock price fell $1.77 per share, or 28.46%, over the following two trading sessions, closing at $4.45 per share on January 5, 2022.

Applied Therapeutics, Inc. (APLT) shareholders have legal options.  If you own shares of Applied Therapeutics, Inc., contact us for more information about your rights.

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

Have You Lost Money In This Company?

If you would like more information about your rights and potential remedies please send us a message.

Having information at your fingertips is easier than ever. Enroll in Robbins LLP’s free investment monitoring service, Stock Watch, for notifications of corporate misconduct impacting the value of your investments, advice on how to hold corporate officers and directors accountable for their misconduct, and to receive information about class action settlements.