Applied Therapeutics News Releases

NEW YORK, Sept. 06, 2023 (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 n…

Regulatory progress for govorestat (AT-007) for the treatment of Classic Galactosemia, with potential NDA submission based on discussions with the FDA as well as EMA Marketing Authorization Application planned in Fall 2023 Phase 3 INSPIRE Trial of govo…

Pre-NDA Meeting to be held with FDA this summer to discuss potential NDA submission for govorestat (AT-007) for treatment of Classic Galactosemia EMA Marketing Authorization Application for govorestat for the treatment of Classic Galactosemia planned i…

The ongoing ARISE-HF Phase 3 global clinical trial is evaluating the safety and efficacy of AT-001 (caficrestat) in improving or preventing worsening of cardiac functional capacity in Diabetic Cardiomyopathy (DbCM); topline data from the study is expec…

Data further elucidates the pathophysiology of sorbitol toxicity, including sorbitol accumulation as the driver of disease in patient-derived motor neurons, as well as in the drosophila model and a new rat model of SORD Deficiency Clinical study data i…

EMA Orphan Designation reflects high unmet need in SORD Deficiency and benefit of govorestat treatment in reducing toxic sorbitol levels New data published in Journal of Clinical Investigation further elucidates the molecular pathophysiology of SORD ne…

Demonstrated Long-term Clinical Benefit of Govorestat in ACTION-Galactosemia Kids Trial Strengthened Balance Sheet with $30 Million Private Placement of Equity Phase 3 INSPIRE Trial of Govorestat in Sorbitol Dehydrogenase (SORD) Deficiency and ARISE-HF…

Govorestat demonstrated consistent long-term clinical outcomes benefit across a range of functional measures in the ACTION-Galactosemia Kids trial, confirming prior biomarker data Govorestat treatment improved activities of daily living, behavior, cogn…

NEW YORK, April 24, 2023 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (NASDAQ: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high…

Progress in Three Phase 3 Trials in Areas of High Unmet Clinical Need, Including Positive Sorbitol Reduction Data from the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency On Track to Report Additional Phase 3 Data Across Multi…