Press Releases

Year

Sep 28, 2023

Applied Therapeutics to Present Baseline Data from Phase 3 ARISE-HF Study Evaluating AT-001 at the 2023 EASD Annual Meeting

The ongoing ARISE-HF Phase 3 global clinical trial is evaluating the efficacy of AT-001 (caficrestat) on cardiac functional capacity in patients with diabetic cardiomyopathy (DbCM) Baseline data from ARISE-HF shows patients with DbCM exhibit reduced cardiac functional capacity resulting in

Sep 06, 2023

Applied Therapeutics Announces Successful Pre-NDA Meeting with the FDA and Confirms Plans to Submit NDA for Govorestat (AT-007) for Treatment of Classic Galactosemia to FDA in Q4 2023

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 need, today announced successful completion of a

Aug 10, 2023

Applied Therapeutics Reports Second Quarter 2023 Financial Results

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 govorestat in Sorbitol Dehydrogenase (SORD)

Jul 25, 2023

Applied Therapeutics Provides Regulatory Update on Galactosemia Program

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 in Fall 2023 NEW YORK, July 25, 2023 (GLOBE

Jun 22, 2023

Applied Therapeutics to Present Baseline Data on the Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association

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 expected in the fourth quarter of this year Baseline

Jun 15, 2023

Applied Therapeutics to Present Data on AT-007 (Govorestat) Treatment in SORD Deficiency at the 2023 Annual Meeting of the Peripheral Nerve Society

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 includes trial design, baseline data and 3-month

May 25, 2023

Govorestat (AT-007) Receives Orphan Medicinal Product Designation from the EMA for Treatment of SORD Deficiency

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 neuropathy and the role of sorbitol in neuronal

May 11, 2023

Applied Therapeutics Reports First Quarter 2023 Financial Results

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 Trial of AT-001 in Diabetic Cardiomyopathy on

Apr 24, 2023

Applied Therapeutics, Inc. Announces $30 Million Private Placement of Equity

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 unmet medical need, today announced it has

Apr 24, 2023

Applied Therapeutics Announces Clinical Benefit of Govorestat (AT-007) in ACTION-Galactosemia Kids Trial; Company Plans to Meet with FDA Regarding Potential NDA Submission

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, cognition, fine motor skills, adaptive skills and

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