Benzinga | Jun 17, 2021 07:18AM EDT

Applied Therapeutics Stock Moves Higher On FDA Fast Track Review For AT-007 In Rare Metabolic Disorder

* The FDA has granted Fast Track designation to Applied Therapeutics Inc's (NASDAQ:APLT) AT-007 to treat Galactosemia, a rare metabolic disease.

* AT-007 is the Company's central nervous system-penetrant Aldose Reductase inhibitor in development for multiple rare metabolic disorders.

* Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process.

* Applied Therapeutics plans to submit a marketing application for Accelerated Approval in Q3 of 2021.

* The FDA has previously granted Orphan Drug Designation and Pediatric Rare Disease status to AT-007 for Galactosemia.

* Price Action: APLT shares are up 4.62% at $24 during the premarket session on the last check Thursday.