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.

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