05:08 PM EDT, 03/28/2024 (MT Newswires) -- Applied Therapeutics ( APLT ) said late Thursday the US Food and Drug Administration has extended the review period by three months for its new drug application, or NDA, for govorestat to treat classic galactosemia, a rare metabolic disease.

The regulator has set a new prescription drug user fee act, or PDUFA, target action date of Nov. 28, the company said.

Applied Therapeutics ( APLT ) said it was notified by the FDA that the regulator needs more time to review additional analyses of data provided by the company after routine information requests.

The regulator decided that the additional information is a "major amendment" to the new drug application, Applied said.

The shares of the company were nearly 12% down in recent trading.

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