Lexicon Pharmaceuticals Says Company Has Made Strategic Decision To Eliminate Its Commercial Operations And Rationalize Resources Across All Functions In Order To Preserve Cash And Focus Its Resources On Advancing Promising Clinical Development Pipeline Following Regulatory Update From FDA; Efforts Expected To Reduce 2025 Operating Costs By $100M
This decision follows the receipt of a "deficiencies preclude discussion" letter from the U.S. Food and Drug Administration (FDA) regarding the Company's 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). The letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.
"While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," said Mike Exton, Ph.D., Lexicon's chief executive officer and director. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact. We are confident that by carefully selecting therapeutic areas where we are the first and only therapy in class, and focusing our R&D efforts where there are significant needs, we can deliver innovations that will meaningfully benefit patients while simultaneously positioning Lexicon to fully realize future growth opportunities."
