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.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted-In: Briefs FDA Fast TrackBiotech News Health Care Small Cap FDA General
