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$Applied Therapeutics(APLT.US$ Applied Therapeutics said regulators had extended the period for reviewing its application for a rare metabolic disease treatment.
The biopharmaceutical company said Thursday that the Food and Drug Administration now has a target action date of Nov. 28 for its application, compared with the previous date of Aug. 28.
The company's application is for govorestat in the treatment of Galactosemia, a rare genetic condition that makes patients unable to metabolize the simple sugar galactose. The condition can lead to neurological complications such as speech and cognition issues.
Applied Therapeutics has received priority review status from the FDA for its new drug application.
The FDA needed additional time to review supplemental analyses of previously submitted data, which were provided by the company in response to routine information requests, the company said. Regulators determined the new information constituted a major amendment to its application, which can lead to a revised review timeline.
The biopharmaceutical company said Thursday that the Food and Drug Administration now has a target action date of Nov. 28 for its application, compared with the previous date of Aug. 28.
The company's application is for govorestat in the treatment of Galactosemia, a rare genetic condition that makes patients unable to metabolize the simple sugar galactose. The condition can lead to neurological complications such as speech and cognition issues.
Applied Therapeutics has received priority review status from the FDA for its new drug application.
The FDA needed additional time to review supplemental analyses of previously submitted data, which were provided by the company in response to routine information requests, the company said. Regulators determined the new information constituted a major amendment to its application, which can lead to a revised review timeline.
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