Core Viewpoint - Lexicon Pharmaceuticals is facing a delay in the FDA review process for the marketing application of Zynquista (sotagliflozin) intended for adults with type 1 diabetes due to the request for additional time to review further clinical data [5] Group 1 - The FDA has requested additional time for the review of the marketing application for Zynquista [5] - The request for more time is related to the submission of additional clinical data [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]