Core Viewpoint - Applied Therapeutics has initiated a process to explore strategic alternatives to maximize shareholder value, which may include mergers, acquisitions, partnerships, and other strategic transactions [1][2][3] Strategic Alternatives - The Board is evaluating a broad range of opportunities to enhance shareholder value, including potential mergers, acquisitions, partnerships, joint ventures, and licensing arrangements [2] - There is no set timetable for the completion of this strategic review process, and the company will not provide further public comments unless necessary [3] Workforce Reduction - The company is reducing its workforce by approximately 46% as part of cost-containment and cash conservation measures [4] Commitment to Patients - The interim CEO emphasized the company's commitment to advancing govorestat for patients with rare diseases while maximizing shareholder value [5] Regulatory Updates - The company completed a Type C meeting with the FDA regarding govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and plans to submit a request for an additional Type C meeting to discuss a potential Phase 3 trial design [6] - Feedback from the FDA regarding govorestat for Classic Galactosemia is being evaluated, with potential discussions for a Phase 3 trial design to follow [7] Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare diseases, with its lead candidate being govorestat, aimed at treating CNS rare metabolic diseases [8]
Applied Therapeutics Announces Corporate Updates