Lexicon to eliminate commercial organization, focus on clinical development

Lexicon (LXRX) Pharmaceuticals announced that the company has made the strategic decision to eliminate its commercial operations and rationalize resources across all functions in order to preserve cash and focus its resources on advancing its promising clinical development pipeline. This prioritization of investment is designed to advance the research and development programs that have the greatest potential for value creation and patient impact. This decision follows the receipt of a “deficiencies preclude discussion” letter from the U.S. Food and Drug Administration regarding the Company’s New Drug Application for Zynquista as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease. The letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time. Details of the Strategic Restructuring: Complete elimination of the Company’s commercial field team and reduction in size of other functions across the organization, including the elimination of all promotional efforts for INPEFA and all planned commercial activities for ZYNQUISTA. A total reduction of approximately 60 percent of employees, effective for most affected employees by December 31st. INPEFA to continue to be manufactured and made available to patients and existing prescribers. An expected reduction of 2025 full year operating costs by $100 million. This amount is in addition to the $40 million in expected 2025 cost savings announced in August as part of a realignment of resources. Reemerging as a Clinical Development-Focused Company: Lexicon will concentrate its resources on the continued research and development of its strong pipeline, including: The Phase 2b PROGRESS study evaluating LX9211 in diabetic peripheral neuropathic pain, with topline data anticipated in Q1 2025. The pivotal Phase 3 SONATA HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy, with enrollment underway. IND-enabling studies of LX9851, a novel, non-incretin oral development candidate in obesity and associated cardiometabolic disorders. Advancing earlier stage opportunities for LX9211 and LX9851 in additional indications. Exploring strategic partnerships to advance and accelerate the value of our pipeline.