Lexicon Pharmaceuticals, following a challenging period despite securing FDA approval for its Type 1 diabetes prospect sotagliflozin in 2023, is undergoing a significant restructuring. The company will focus on promoting sotagliflozin in heart failure, where it is marketed as Inpefa, and on its potential launch in the U.S. for Type 1 diabetes and chronic kidney disease under the name Zynquista. As part of this strategy, Lexicon will reduce its workforce by over 75 employees, aiming to save around $40 million by 2025 and ensure continued funding for critical clinical programs.
The company's CEO, Mike Exton, Ph.D., emphasized that Lexicon is focused on resource allocation to capitalize on its commercial and pipeline opportunities. Despite earlier FDA rejections of sotagliflozin for Type 1 diabetes, Lexicon plans to refile its U.S. application for Zynquista to aid glycemic control in adults with diabetes and CKD. Additionally, the company remains committed to its R&D programs, including potential treatments for hypertrophic cardiomyopathy, diabetic neuropathic pain, and obesity.
Lexicon's fortunes began to improve in May with the FDA approval of Inpefa, a once-daily pill aimed at reducing heart failure risks in adults with conditions like Type 2 diabetes and CKD. However, the regulatory journey for sotagliflozin has been fraught with setbacks, including a 2019 FDA rejection and a withdrawn European marketing authorization in 2022. Despite these challenges, Lexicon is optimistic about its upcoming FDA decision for Zynquista, expected by December 20.
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