Xeris Pharmaceuticals Inc. (NASDAQ: XERS) shares were halted briefly on Tuesday after the firm announced that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for Gvoke, its treatment of severe hypoglycemia in pediatric and adult patients with diabetes.
For some quick background, Gvoke is the first glucagon product approved that can be administered via a prefilled syringe (Gvoke PFS) or auto-injector (Gvoke HypoPen), vastly reducing the steps to prepare and administer glucagon in the event of severe hypoglycemia, or dangerously low blood sugar levels.
These innovative formats are designed to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer quickly and simply.
The FDA’s approval is based on positive results from three Phase 3 clinical trials evaluating the efficacy, safety and utility of Gvoke in treating severe hypoglycemia when compared with conventional glucagon emergency kits among adults and children with type 1 diabetes.
The studies demonstrated 100% treatment success in children and 99% treatment success in adults. Usability research evaluating the Gvoke PFS and Gvoke HypoPen demonstrated nearly 100% success rates in administering a full dose of glucagon using the simple two-step administration process.
Jeff Hitchcock, founder and president of Children With Diabetes, commented:
Until now, many people may have been hesitant to use conventional glucagon kits because the complex preparation felt confusing and perhaps overwhelming. With GVOKE as a new glucagon option, we gain an easy to use and effective solution to a dangerous and stressful event.
Shares of Xeris traded at $10.94 on Tuesday, in a 52-week range of $6.85 to $27.98. The consensus price target is $21.25.