Cycle Pharmaceuticals to Acquire Applied Therapeutics Applied Therapeutic’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT; “Applied”), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced a definitive agreement for Cycle Group Holdings Limited (“Cycle”) to acquire Applied Therapeutics. Applied Therapeutics is a clinical-sta...
Applied Therapeutics Announces Corporate Updates NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced that Applied Therapeutics’ Board of Directors (the “Board”) has initiated a process to explore strategic alternatives for the Company. The Board intends to evaluate a broad range of opportunities to maximize shareholder value. Strategic alternatives under consideration may include, but are not limited to, mergers, ...
Applied Therapeutics Reports Third Quarter 2025 Financial Results – Update on regulatory strategy for govorestat for the treatment of CMT-SORD following receipt of Type C meeting minutes – Meeting scheduled with the FDA in 4Q 2025 to discuss govorestat for the treatment of Classic Galactosemia – New data on govorestat for the treatment of PMM2-CDG published in JIMD and presented at the 2025 ASHG Annual Meeting – Announces Board of Directors Leadership Transition NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-s...
Applied Therapeutics Provides Update Following Meeting with FDA NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the Company), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced that the Company completed a meeting with the U.S. Food and Drug Administration (FDA) to discuss the potential new drug application (NDA) submission for govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (SORD) Deficiency (CMT-SORD) in the third quarter of 2025. The Company i...
Applied Therapeutics Reports Second Quarter 2025 Financial Results - CMT-SORD program advances; meeting scheduled with the FDA in Q3 2025 to discuss govorestat for the treatment of CMT-SORD - Presented full 12-month clinical results and new topline data from INSPIRE Phase 2/3 trial of govorestat for the treatment of CMT-SORD at PNS 2025 Annual Meeting highlighting slowed progression of disease observed via MRI at 24 months - Launched new sponsored Sorbitol Assay to support identification of patients suspected of having CMT-SORD - Entered into out-licensing agreement with Biossil, Inc. fo...
Applied Therapeutics Announces Key Leadership Appointments Evan Bailey, MD, promoted to Chief Medical Officer, succeeding Riccardo Perfetti, MD, PhDDottie Caplan promoted to Executive Vice President, Patient Advocacy and Government Affairs NEW YORK, June 17, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced key appointments to its executive leadership team with the promotions of Evan Bailey, MD, to Chief Medical Officer (CMO), effective June 15, 2025, and Dottie...
Applied Therapeutics Presents Full 12-Month Clinical Results and New Topline Data from INSPIRE Phase 2/3 Trial of Govorestat in CMT-SORD in Late-Breaking Oral Presentation at the Peripheral Nerve Society 2025 Annual Meeting Slowing of progression of disease observed via MRI at 24 months Improvements in outcomes and reduction in sorbitol maintained through 24 months Statistically significant correlation between absolute reduction in sorbitol and change in 10MWRT and CMT-FOM Lower Limb domain at 12 months, though the primary endpoint of 10MWRT at 12 months was not statistically signifi...
Applied Therapeutics Reports First Quarter 2025 Financial Results - Company to present full 12-month clinical data and new topline 18-month and 24-month data from INSPIRE registrational Phase 3 trial of govorestat in CMT-SORD Deficiency at the Peripheral Nerve Society 2025 Annual Meeting - Review of govorestat development programs for Classic Galactosemia and CMT-SORD Deficiency ongoing NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare d...
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