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

by Vandana Singh, Benzinga Editor

June 17, 2021 7:18 AM | 1 min read |

The FDA has granted Fast Track designation to Applied Therapeutics Inc's 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.

Posted In: Biotech News Health Care Small Cap FDA General Briefs FDA Fast Track Galactosemia

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