KoXeris Pharma Inc. (XERS) stock prices surged by 21.36% as of the market closing on August 23rd 2021. This brought the price per share up to USD$2.67 at the end of the trading day. Subsequent premarket fluctuations saw the stock dip by 3.75%, bringing it down to USD$2.57.
Approval of Gvoke Kit sNDA
August 23rd 2021 saw XERS stock announce the approval of its supplemental new drug application for Gvoke Kit by the United States Food and Drug Administration. The company’s proprietary treatment serves to address hyperglycemia in pediatric and adult patients with diabetes 2 years of age and higher. The Gvoke Kit will be available as a 1mg/0.2 mL single dose vial and syringe kit. Each kit will contain one single-dose sterile syringe with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dost), along with one single-dose vial containing 0.2 mL of solution.
Scope of XERS Stock’s Approval
Following approval be the U.S FDA, the company expects to begin manufacturing scale up immediately. Commercial availability of Gvoke Kit is forecasted for early in the first quarter of 2022. Following its launch, the company will offer three difference administration options: Gvoke HypoPen, Gvoke PFS, Gvoke Kit. This allows for greater patient choice in a ready-to-use rescue product for roughly 6.8 million people in the United States who rely on insulin and are at risk of a severe hypoglycemic event.
Benefits of Gvoke Kit
The innovative formats facilitate the provision of reliable, ready-to-use liquid glucagon while offering a myriad of administrative options for patients and caregivers. Gvoke Kit serves to reduce the number of steps by eliminating reconstitution, which is critical for patients or caregivers who prefer to draw up their Gvoke rescue dose using a vial and syringe. This is especially helpful because it addresses the most common mistake in the correct administration of the conventional glucagon kit.
XERS Stock’s Development Efforts
The approval of the supplemental New Drug Application by the U.S FDA was supported by the company’s pharmacokinetic study. The study demonstrated a 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).
Future Outlook for XERS Stock
XERS stock reported a strong quarter with its announcement of the approval of an sNDA for the company’s proprietary Gvoke Kit. The company is keen to leverage the resources at its disposal to push for the commercialization and proliferation of its new treatment. Investors hope this will translate into significant and sustained increases in shareholder value.
