Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter

Dow Jones

2024-11-28

By Josh Beckerman

Applied Therapeutics shares dropped after hours after disclosing that the Food and Drug Administration issued a complete response letter for its new drug application for govorestat for treatment of classic galactosemia.

The company's stock was 76% lower, at $2.04. It closed the regular session at $8.57, down about 16%.

The company said it is reviewing the FDA's feedback and plans to immediately request a meeting to discuss requirements for a potential resubmission of the NDA or appeal of the decision along with appropriate next steps.

An FDA complete response letter indicates that an application can't be approved in its current form.

Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol dehydrogenase deficiency.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

November 27, 2024 17:33 ET (22:33 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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