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AT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months AT-001 treatment resulted in a statistically significant...

NDA submitted to FDA and MAA validated by EMA in December 2023 Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term...

Regulatory submissions on track for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA in 4Q 2023 Two Upcoming Phase 3 Trial Readouts, with ARISE-HF Trial of AT-001...

NEW YORK, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated...

Forum to be Webcast Live Topline Phase 3 Data Readout from ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy On Track for 4Q 2023 NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) --...

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...

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...

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...

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...

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...