Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)

Core Insights - Lexicon Pharmaceuticals received a complete response letter (CRL) from the FDA regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD) [4] - The company has decided to discontinue launch preparations for Zynquista and will focus on its clinical development pipeline [2] - Lexicon is committed to advancing its clinical pipeline, particularly LX9211 for diabetic neuropathic pain (DPNP), with top line data from the PROGRESS Phase 2b study expected in Q1 2025 [6] Company Overview - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to study nearly 5,000 genes and identify over 100 protein targets with therapeutic potential [5] - The company has a pipeline of promising drug candidates in various stages of development, targeting conditions such as neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, and metabolism [5]