Lexicon Pharmaceuticals is set to lay off more than 75 employees—approximately 50% of its current field force—by the end of September as part of a broader restructuring effort. This decision follows a strategic review of the company’s commercial and pipeline priorities, with a focus on its heart failure drug, Inpefa, and the potential U.S. launch of its diabetes treatment, Zynquista.
Lexicon’s recent successes include the FDA approval of Inpefa, a once-daily pill for heart failure, in May 2023. Inpefa, which targets patients with heart failure, Type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular risks, represents a significant milestone for the company. However, despite these achievements, Lexicon has faced significant challenges, particularly in gaining regulatory approval for its Type 1 diabetes drug, sotagliflozin, under the brand name Zynquista.
The layoffs and restructuring are aimed at streamlining Lexicon’s operations and reallocating resources to maximize the potential of its key products. The company expects the move to generate around $40 million in cost savings by 2025, ensuring that critical clinical programs, including those for heart failure and diabetes, remain fully funded.
CEO Mike Exton, Ph.D., emphasized the strategic nature of the restructuring, stating, “We are focusing our resources on the areas where we have the greatest potential to lead and succeed, building on the strengths of our commercial team and our recent successes.”
Lexicon’s journey with sotagliflozin has been fraught with regulatory hurdles. The drug was initially rejected by the FDA in 2019 for its use in Type 1 diabetes patients who struggle to control their blood sugar with insulin alone. After appealing the decision, Lexicon faced another rejection in 2020 due to safety concerns. Despite these setbacks, the drug was approved in Europe under the name Zynquista, though its marketing authorization was later withdrawn in 2022.
Undeterred, Lexicon has continued to pursue U.S. approval for Zynquista. In March 2024, after receiving feedback from the FDA, the company announced plans to resubmit its application, which it has since done. The FDA has set a decision date of December 20, 2024, for the drug’s potential approval as an adjunct to insulin therapy for Type 1 diabetes patients with CKD.
In addition to its focus on heart failure and diabetes treatments, Lexicon plans to continue investing in research and development. This includes further studies on sotagliflozin for hypertrophic cardiomyopathy, as well as advancing other pipeline candidates like LX9211 for diabetic neuropathic pain and LX9851 for obesity and weight management.
Lexicon’s strategic shift underscores the challenges and opportunities facing mid-sized pharmaceutical companies as they navigate complex regulatory environments and strive to bring innovative therapies to market.
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