Lexicon Pharmaceuticals (LXRX) said Friday it has received a complete response letter from the US Food and Drug Administration related to Zynquista as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.
The FDA rejection "aligns with the company's previously disclosed strategic decision to discontinue launch preparations for Zynquista and focus solely on its clinical development pipeline," Lexicon said.
The company's shares were falling nearly 11% in recent after-hours activity.