Applied Therapeutics Shares Slip 13% After FDA Extends Drug Review
By Ben Glickman
Shares of Applied Therapeutics sank after regulators extended the company's target action date for its new drug application.
The stock was down 13% to $5.90 in after-hours trading on Thursday, following a 0.7% drop in the regular session. Shares have doubled so far this year.
The biopharmaceutical company said the Food and Drug Administration had set a new target action date of Nov. 28 from a previous target date of Aug. 28.
The company is waiting for a response on its new drug application for govorestat in the treatment of Galactosemia, a rare metabolic disease that inhibits the ability to process a kind of simple sugar.
Regulators told the company they needed more time to review supplemental analyses of previously submitted data. Those analyses were provided by the company in response to routine information requests, it said, but were determined to be a major amendment to its application.
Govorestat is the company's lead drug candidate and has received priority review status from the FDA.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
March 28, 2024 18:04 ET (22:04 GMT)
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