Core Insights - Lexicon Pharmaceuticals, Inc. announced the presentation of clinical data on adipose tissue distribution in non-diabetic patients treated with sotagliflozin at the 22nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025) [1] - The data comes from the SOTA-P-CARDIA trial, which focused on patients with heart failure with preserved ejection fraction (HFpEF) [2] - Craig Granowitz, M.D., Ph.D., highlighted that the new data supports sotagliflozin's differentiated benefits compared to SGLT2 inhibitors [3] Sotagliflozin Overview - Sotagliflozin is an oral inhibitor of SGLT2 and SGLT1, which are involved in glucose regulation [4] - The drug has been studied in various patient populations, including approximately 20,000 patients across heart failure, diabetes, and chronic kidney disease [4] - Sotagliflozin is also under investigation for hypertrophic cardiomyopathy (HCM) [4] Company Background - Lexicon Pharmaceuticals aims to pioneer medicines that transform patients' lives through its Genome5000™ program, which has identified over 100 protein targets with therapeutic potential [5] - The company has a pipeline of drug candidates in various stages of development, focusing on neuropathic pain, HCM, metabolism, and other indications [5]

Core Insights - Lexicon Pharmaceuticals is working on resubmitting the New Drug Application (NDA) for Zynquista (sotagliflozin) to the FDA, following a complete response letter issued in December 2024 due to concerns about diabetic ketoacidosis risk [1][2] - The company has submitted additional clinical data from ongoing studies to support the benefit-risk profile of Zynquista in adults with type 1 diabetes (T1D) [2] - Feedback from the FDA is now expected in the fourth quarter of 2025, later than the previously anticipated end of September timeline [1] Group 1 - The FDA's complete response letter in December 2024 raised concerns about the increased risk of diabetic ketoacidosis associated with Zynquista [2] - Lexicon has conducted three ongoing studies to support the resubmission: STENO1, SUGARNSALT, and SOPHIST, which involve approximately 20,000 patients [2][3] - Sotagliflozin is an oral SGLT1/SGLT2 inhibitor aimed at improving glycemic control in adults with T1D [1][3] Group 2 - Lexicon Pharmaceuticals utilizes a unique genomics target discovery platform, Genome5000™, to identify therapeutic protein targets [5] - The company has a diverse pipeline of drug candidates in various stages of development, including treatments for neuropathic pain, hypertrophic cardiomyopathy, and obesity [5] - Lexicon's mission is to pioneer innovative medicines that transform patients' lives through precise targeting of proteins [5]