Business
Xeris Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke VialDx™ (glucagon) for Use as a Diagnostic Aid
First concentrated, ready-to-dilute liquid glucagon available for growing procedural gastroenterology market American Regent to commercialize GVOKE VialDx™
About this update from Xeris Biopharma Holdings, Inc.
[{"type":"text","content":"\nFirst concentrated, ready-to-dilute liquid glucagon available for growing procedural gastroenterology market\n\nAmerican Regent to commercialize GVOKE VialDx™\n\nAvailability is expected in the third quarter of 2025\n\n CHICAGO--(BUSINESS WIRE)--\nXeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.\n\nXeris also announced it has partnered with American Regent to commercialize Gvoke VialDx. Under the terms of the agreement, Xeris will be responsible for product supply, and American Regent will be responsible for the commercialization of Gvoke VialDx in the U.S. Financial terms were not disclosed.\n\n“We’re excited about the approval of Gvoke VialDx and our partnership with American Regent. Gvoke VialDx has the potential to modernize the handling and administration of glucagon for diagnostic procedures,” said Kevin McCulloch, President and COO of Xeris. “American Regent is the perfect partner for Gvoke VialDx given their long history as a leading provider of high quality, sterile injectable products to the hospital and acute care marketplace.\"\n\nJoann Gioia, Vice President and Chief Commercial Officer at American Regent, said, “We are eager to bring our commercial expertise in the hospital and acute care setting to our partnership with Xeris and contribute to the success of Gvoke VialDx. With an estimated 20 million gastrointestinal endoscopic procedures performed annually, the addition of Gvoke VialDx to our portfolio aligns perfectly with our mission to provide patients with the essential medicines they need.”\n\nGvoke VialDx will be available as a 1-count or 10-count package of 1 mg per 0.2 mL single-dose vials.\n\nIndications and Important Safety Information\nGvoke is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes.\n\nGvoke VialDx is a gastrointestinal motility inhibitor...