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Applied Therapeutics, Inc. (APLT)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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5.16-0.18 (-3.37%)
At close: 04:00PM EDT
5.00 -0.16 (-3.10%)
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  • GlobeNewswire

    Applied Therapeutics to Present Results from Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at ACC 2024

    NEW YORK, April 04, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that it will present full results from the Phase 3 ARISE-HF study evaluating AT-001 (caficrestat) in Diabetic Cardiomyopathy (DbCM) in an oral presentation at the 2024 American College of Cardiology (ACC) Annual Scientific Sess

  • Reuters

    UPDATE 1-US FDA extends review of Applied Therapeutics' genetic disease drug

    The U.S. Food and Drug Administration has extended its review of Applied Therapeutics' experimental drug to treat galactosemia, a rare genetic metabolic disease, the company said on Thursday. There are currently no approved treatments for the disease in the United States, which has about 3,000 Galactosemia patients. The FDA delayed its decision on the drug, govorestat, saying it requires additional time to review supplemental analyses submitted by the company.

  • GlobeNewswire

    Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia

    NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for govorestat (AT-007) for the treatment of Classic Galactosemia by three months. The FDA has set a new Prescri