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Biotech Stocks Facing FDA Decision In January 2019

Lexicon Pharmaceuticals
Lexicon Pharmaceuticals

An FDA panel is slated to review Zynquista (sotagliflozin), an investigational oral treatment as an adjunct therapy to insulin for adults with type 1 diabetes, on January 17, 2019.

Zynquista, developed by Sanofi (SNY) in partnership with Lexicon Pharmaceuticals Inc. (LXRX) is an oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar (glucose) resulting in improved glucose control and additional clinical benefits.

The final decision of the FDA on Zynquista is expected on March 22, 2019.

In clinical trials, Zynquista lowered blood glucose and helped patients with type 1 diabetes (T1D) lose weight and control blood pressure. However, the drug candidate was associated with higher rates of diabetic ketoacidosis, a potentially life-threatening complication.

According to GlobalData Healthcare, Zynquista is expected to reach peak U.S. sales of $1.3 billion in 2024.

LXRX closed Friday’s (Dec.21, 2018) trading at $6.34, down 8.65%.