Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

Core Insights - Lexicon Pharmaceuticals is preparing for the launch of Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease, with a PDUFA goal date set for December 20, 2024 [1][2] Group 1: Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives through its Genome5000™ program, which has identified over 100 protein targets with significant therapeutic potential [3] - The company has successfully launched INPEFA® (sotagliflozin) in the United States and has a pipeline of promising drug candidates in various stages of development, including neuropathic pain and diabetes [3] Group 2: Regulatory and Market Position - The FDA has acknowledged the resubmission of Lexicon's New Drug Application (NDA) for sotagliflozin, indicating it is a complete response to the previous action letter from 2019 [1] - If approved, Zynquista will represent Lexicon's second NDA approval and commercial launch within two years, showcasing the company's ability to advance products from discovery to regulatory approval [2]