The FDA has approved Xeris Pharmaceuticals Inc Inc's (NASDAQ: XERS) Gvoke Kit for severe hypoglycemia in pediatric and adult patients with diabetes ages two years and above.
Gvoke Kit is the first ready-to-use glucagon available in a single-use vial and single-use syringe kit for rescue.
It eliminates the need for reconstitution.
With the approval, Xeris will begin manufacturing scale-up immediately and anticipates Gvoke Kit availability in early Q1 of 2022.
The approval was supported by a pharmacokinetic study demonstrating bioequivalence of a 1 mg Gvoke dose administered via a vial and syringe kit (Gvoke Kit) to that of 1 mg Gvoke administered as a pre-filled syringe (Gvoke PFS).
Xeris has already received FDA approval in 2019 for Gvoke PFS and Gvoke HypoPen (glucagon injection) for severe hypoglycemia in pediatric and adult patients with diabetes ages two years and above.
Price Action: XERS shares are up 27.3% at $2.80 during the market session on the last check Monday.