Xeris Pharmaceuticals Inc (NASDAQ:XERS) is trading significantly higher Monday after the company announced U.S. Food and Drug Administration approval of its New Drug Application for Gvoke for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes two years of age and older.

Xeris Pharmaceuticals said it will begin manufacturing scale up immediately and it anticipates its Gvoke Kit will be available in the first quarter of 2022.

“Offering three different administration options - Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the U.S. who rely on insulin and are at-risk of a severe hypoglycemic event," said Paul Edick, chairman and CEO of Xeris Pharmaceuticals.

Xeris Pharmaceuticals is a specialty pharmaceutical company leveraging its novel non-aqueous formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations. 

Price Action: Xeris Pharmaceuticals has traded as high as $7.94 and as low as $2.16 over a 52-week period.

At last check Monday, the stock was up 26.10% at $2.77.