Applied Therapeutics Reports Second Quarter 2023 Financial Results
August 10, 2023 07:00 ET
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Applied Therapeutics
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...
Applied Therapeutics Provides Regulatory Update on Galactosemia Program
July 25, 2023 07:00 ET
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Applied Therapeutics
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...
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
June 22, 2023 07:00 ET
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Applied Therapeutics
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...
Applied Therapeutics to Present Data on AT-007 (Govorestat) Treatment in SORD Deficiency at the 2023 Annual Meeting of the Peripheral Nerve Society
June 15, 2023 07:00 ET
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Applied Therapeutics
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...
Govorestat (AT-007) Receives Orphan Medicinal Product Designation from the EMA for Treatment of SORD Deficiency
May 25, 2023 07:00 ET
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Applied Therapeutics
EMA Orphan Designation reflects high unmet need in SORD Deficiency and benefit of govorestat treatment in reducing toxic sorbitol levelsNew data published in Journal of Clinical Investigation further...
Applied Therapeutics Reports First Quarter 2023 Financial Results
May 11, 2023 07:00 ET
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Applied Therapeutics
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...
Applied Therapeutics Announces Clinical Benefit of Govorestat (AT-007) in ACTION-Galactosemia Kids Trial; Company Plans to Meet with FDA Regarding Potential NDA Submission
April 24, 2023 07:00 ET
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Applied Therapeutics
Govorestat demonstrated consistent long-term clinical outcomes benefit across a range of functional measures in the ACTION-Galactosemia Kids trial, confirming prior biomarker dataGovorestat treatment...
Applied Therapeutics, Inc. Announces $30 Million Private Placement of Equity
April 24, 2023 07:00 ET
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Applied Therapeutics
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...
Applied Therapeutics Reports Fourth Quarter and Year-end 2022 Financial Results
March 23, 2023 06:30 ET
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Applied Therapeutics
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...
Applied Therapeutics to Present at the Cowen 43rd Annual Health Care Conference
March 01, 2023 07:00 ET
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Applied Therapeutics
NEW YORK, March 01, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...