Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application

Dow Jones

Nov 28, 2024

By Sabela Ojea

Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical application.

Shares dropped 16% to $8.57 in post-marketing trading. Through Wednesday's close, the stock has more-than-doubled since the beginning of the year.

The FDA issues a complete response letter when it decides not to approve a new drug application in its present form.

The biopharmaceutical company on Wednesday said it is reviewing the feedback from the FDA and plans to immediately request a meeting to potentially resubmit the NDA for the treatment of galactosemia or appeal the decision along with appropriate next steps.

"We are disappointed by the FDA's decision today," Chief Executive Shoshana Shendelman said.

Galactosemia is a progressive and debilitating disease without any existing treatment options, the executive added.

Overall, Galactosemia a rare genetic disorder that prevents the body from processing galactose.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

November 27, 2024 16:33 ET (21:33 GMT)

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Through Wednesday's close, the stock has more-than-doubled since the beginning of the year. \n\n\n  The FDA issues a complete response letter when it decides not to approve a new drug application in its present form. \n\n\n  The biopharmaceutical company on Wednesday said it is reviewing the feedback from the FDA and plans to immediately request a meeting to potentially resubmit the NDA for the treatment of galactosemia or appeal the decision along with appropriate next steps. \n\n\n  \"We are disappointed by the FDA's decision today,\" Chief Executive Shoshana Shendelman said. \n\n\n  Galactosemia is a progressive and debilitating disease without any existing treatment options, the executive added. \n\n\n  Overall, Galactosemia a rare genetic disorder that prevents the body from processing galactose. \n\n\n \n\n\n  Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  November 27, 2024 16:33 ET (21:33 GMT)\n\n\n  Copyright (c) 2024 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}