Lexicon receives CRL for Zynquista

Lexicon (LXRX) Pharmaceuticals announced it has received a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application for Zynquista as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease. This expected communication from the FDA aligns with the company’s previously disclosed strategic decision to discontinue launch preparations for Zynquista and focus solely on its clinical development pipeline. “We are sincerely grateful to the patients and physicians who participated in our Zynquista clinical trials, and the broader diabetes community who strongly advocated for Zynquista’s approval,” said Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline, including our near-term focus on LX9211 for diabetic neuropathic pain (DPNP) with top line data from our PROGRESS Phase 2b study anticipated in Q1 2025, and pursuing innovations that we believe can profoundly benefit patients.”