Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA

Core Viewpoint - Lexicon Pharmaceuticals has decided to eliminate its commercial operations and rationalize resources to focus on advancing its clinical development pipeline, aiming to reduce operating costs by $100 million in 2025 [1][4]. Group 1: Strategic Restructuring - The company will completely eliminate its commercial field team and reduce the size of other functions, including all promotional efforts for INPEFA® and planned commercial activities for ZYNQUISTA [4]. - Approximately 60$100 million, in addition to $40 million in cost savings previously announced [4]. Group 2: Focus on R&D Pipeline - Lexicon will concentrate on its R&D pipeline, including the Phase 2b PROGRESS study for LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data expected in Q1 2025 [5]. - The pivotal Phase 3 SONATA HCM study for sotagliflozin in hypertrophic cardiomyopathy (HCM) is currently enrolling participants [5]. - The company is also advancing IND-enabling studies for LX9851, a novel oral candidate for obesity and associated cardiometabolic disorders, and exploring strategic partnerships to enhance its pipeline [5]. Group 3: Regulatory Challenges - The decision to restructure follows a "deficiencies preclude discussion" letter from the FDA regarding the New Drug Application for Zynquista™ for type 1 diabetes and chronic kidney disease, indicating issues that prevent further discussion on labeling and post-marketing requirements [2][3].