APLT - Applied Therapeutics trades higher on FDA Fast Track designation for rare metabolic disorder

syahrir maulana/iStock via Getty Images Applied Therapeutics (APLT) has added ~6.8% in the pre-market after the company announced that the FDA has granted the Fast Track designation to AT-007 for the treatment of Galactosemia, a rare metabolic disorder. Fast Track designation is designed to accelerate the development and review of drug which are on track to serve an unmet medical need in the treatment of serious conditions. If certain criteria are met, such programs will also be able to win Accelerated Approval and Priority Review enabling them to reach patients sooner. Applied Therapeutics is planning to submit a New Drug Application ((NDA)) for accelerated approval of AT-007 in Q3 2021 for the treatment of Galactosemia. In June 2020, the company reported additional supportive biomarker efficacy and safety data for AT-007 in Galactosemia.

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Applied Therapeutics trades higher on FDA Fast Track designation for rare metabolic disorder