Sotagliflozin

Lexicon Pharmaceuticals to lay off 60% of workforce, eliminate commercial organization, and save $100 million in operating costs following FDA's 'deficiencies' in Zynquista approval application. The company will pivot to focus on research pipeline, including Phase 2 diabetic peripheral neuropathic pain drug and preclinical obesity therapy.

Lexicon Pharmaceuticals reported $1.8M in Q3 2023 revenues from INPEFA sales, with a net loss of $(64.8)M. The company is commercializing INPEFA for cardiovascular risks and pursuing FDA approval for ZYNQUISTA for type 1 diabetes. Lexicon faces challenges including commercialization risks, clinical trial outcomes, and financial needs, but aims to manage these through strategic initiatives and collaborations.

Lexicon Pharmaceuticals faces FDA rejections for sotagliflozin, its type 1 diabetes and chronic kidney disease drug, with an advisory committee voting against its approval. Despite setbacks, Lexicon continues development and anticipates an FDA decision by December 20.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 that Zynquista (sotagliflozin) benefits do not outweigh risks in adults with type 1 diabetes and chronic kidney disease. FDA is reviewing approval for Zynquista as an adjunct to insulin, with a goal date of Dec. 20, 2024. Concerns include uncertainties about benefits for patients with mild-to-moderate chronic kidney disease and risks of diabetic ketoacidosis.

Lexicon Pharmaceuticals announced the FDA Advisory Committee's 11-3 vote against approving Zynquista (sotagliflozin) as an adjunct to insulin therapy for type 1 diabetes and chronic kidney disease, citing risks. The FDA previously approved sotagliflozin for heart failure and type 2 diabetes in 2023. Lexicon resubmitted the NDA in June, anticipating a potential launch in early 2025. Viatris obtained exclusive licensing rights for sotagliflozin outside the U.S. and Europe.

Lexicon Pharmaceuticals announced the FDA EMDAC's 11-3 vote against Zynquista's approval for T1D and CKD, despite community support. The PDUFA target action date is December 20, 2024.

FDA staff raises safety concerns about sotagliflozin for type 1 diabetes with chronic kidney disease, focusing on diabetic ketoacidosis risks and treatment durability.

Lexicon Pharmaceuticals sells sotagliflozin rights outside U.S. and Europe to Viatris for $25M upfront, with potential $200M in milestones. Lexicon focuses on Type 1 diabetes expansion, awaiting FDA advisory panel review on Oct 31 for sotagliflozin use in Type 1 diabetes and chronic kidney disease patients. The approval could open a $400M U.S. market, impacting Lexicon's stock by up to 40%.