Xeris Pharmaceuticals’ (NASDAQ:XERS) ready-to-use glucagon auto-injector showed comparable efficacy with Novo Nordisk’s GlucaGen HypoKit for achieving plasma glucose of greater than 70 mg/dl or greater than or equal to 20 mg/dl increase in glucose concentration within 30 minutes of glucogon administration in a Phase 3 non-inferiority study in Europe and North America.
Xeris gains 0.7% to in $9.61 premarket trading.
Study conducted among 132 adults with type 1 diabetes to evaluate the Xeris RTU glucagon auto-injector as a treatment for severe hypoglycemic events.
Study also found that time to resolution of hypoglycemia symptoms as well as time to resolution of the overall feeling of hypoglycemia was comparable between Xeris RTU glucagon and the marketed emergency kit.
Overall, no safety or tolerability concerns were noted.
NDA for the investigational product, to be branded Gvoke HypoPen in the U.S., is currently under review with the U.S. Food and Drug Administration, with a decision expected Sept. 10, 2019.
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