FDA panel vote leaves Lexicon’s Zynquista hopes hanging by a thread

1 November 2024

Texas, USA-based biopharma Lexicon Pharmaceuticals (Nasdaq: LXRX) was trading nearly 36% lower on Friday morning.

Markets were reacting to the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review the company’s New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).

The panel voted by 11 to three that the benefits of Zynquista do not outweigh the risks in adults with T1D and CKD.

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