Lexicon Pharmaceuticals Inc. (NASDAQ: LXRX) shares jumped on Friday after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the Marketing Authorization of Zynquista (sotagliflozin).
Ultimately, CHMP recommended approval of sotagliflozin in the European Union in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes mellitus, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
For some quick background: sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.
The opinion is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin.
Separately, sotagliflozin is also currently being reviewed by the U.S. Food and Drug Administration (FDA) and has the potential to be the first oral antidiabetic drug approved in the United States for use together with insulin therapy to improve glycemic control in adults living with type 1 diabetes.
Shares of Lexicon were last seen up about 21% at $6.43 on Friday, in a 52-week range of $4.26 to $13.97. The consensus price target is $21.33.