The U.S. FDA has denied Lexicon Pharmaceuticals appeal against the rejection of its add-on treatment for type 1 diabetes, marking the company’s third major setback this year and sending its shares plunging. Lexicon says it intends to reappeal the decision against Zynquista’s approval with the FDA’s Center for Drug Evaluation and Research (CDER), effectively going over the head of the current FDA office with which it is dealing. Lexicon says it does not intend to run new analyses for review with CDER. The U.S. FDA in March declined to approve Zynquista, two months after a panel of independent advisers to the health regulator raised concerns of the risk of a complication called diabetic ketoacidosis (DKA). Learn More