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Xeris Announces FDA Approval Of Supplemental New Drug Application Of Gvoke VialDx For Use As A Diagnostic Aid; Xeris Also Announced It Has Partnered With American Regent To Commercialize Gvoke VialDx; Financial Terms Were Not Disclosed

Benzinga·03/17/2025 12:10:39
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First concentrated, ready-to-dilute liquid glucagon available for growing procedural gastroenterology market

American Regent to commercialize GVOKE VialDx

Availability is expected in the third quarter of 2025

Xeris 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.

Xeris 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.

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