Xeris Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke VialDx™ (glucagon) for Use as a Diagnostic Aid
Xeris Biopharma Holdings (Nasdaq: XERS) has received FDA approval for its supplemental new drug application (sNDA) of Gvoke VialDx™, the first concentrated, ready-to-dilute liquid glucagon for use as a diagnostic aid during radiologic examinations in adult patients.
The company has partnered with American Regent for commercialization in the U.S., with Xeris handling product supply while American Regent manages commercialization efforts. The product will be available in 1-count or 10-count packages of 1 mg per 0.2 mL single-dose vials, with market availability expected in Q3 2025.
This development targets the growing procedural gastroenterology market, with an estimated 20 million gastrointestinal endoscopic procedures performed annually. The product is designed to temporarily inhibit movement of the gastrointestinal tract in adult patients during radiologic examinations.
Xeris Biopharma Holdings (Nasdaq: XERS) ha ricevuto l'approvazione della FDA per la sua domanda di supplemento di nuova droga (sNDA) per Gvoke VialDx™, il primo glucagone liquido concentrato e pronto per essere diluito, utilizzato come ausilio diagnostico durante le indagini radiologiche in pazienti adulti.
L'azienda ha collaborato con American Regent per la commercializzazione negli Stati Uniti, con Xeris che gestisce la fornitura del prodotto mentre American Regent si occupa degli sforzi di commercializzazione. Il prodotto sarà disponibile in confezioni da 1 o 10 fiale monodose da 1 mg per 0,2 mL, con disponibilità sul mercato prevista per il Q3 2025.
Questo sviluppo si rivolge al crescente mercato della gastroenterologia procedurale, con circa 20 milioni di procedure endoscopiche gastrointestinali eseguite annualmente. Il prodotto è progettato per inibire temporaneamente il movimento del tratto gastrointestinale nei pazienti adulti durante le indagini radiologiche.
Xeris Biopharma Holdings (Nasdaq: XERS) ha recibido la aprobación de la FDA para su aplicación suplementaria de nuevo medicamento (sNDA) de Gvoke VialDx™, el primer glucagón líquido concentrado y listo para diluir, utilizado como ayuda diagnóstica durante los exámenes radiológicos en pacientes adultos.
La compañía se ha asociado con American Regent para la comercialización en EE. UU., con Xeris encargándose del suministro del producto mientras que American Regent gestiona los esfuerzos de comercialización. El producto estará disponible en paquetes de 1 o 10 viales de dosis única de 1 mg por 0.2 mL, con disponibilidad en el mercado esperada para el Q3 2025.
Este desarrollo apunta al creciente mercado de la gastroenterología procedimental, con un estimado de 20 millones de procedimientos endoscópicos gastrointestinales realizados anualmente. El producto está diseñado para inhibir temporalmente el movimiento del tracto gastrointestinal en pacientes adultos durante los exámenes radiológicos.
Xeris Biopharma Holdings (Nasdaq: XERS)는 성인 환자의 방사선 검사 중 진단 보조 용도로 사용되는 첫 번째 농축된 액체 글루카곤 Gvoke VialDx™의 보충 신약 신청(sNDA)에 대해 FDA 승인을 받았습니다.
회사는 미국에서 상업화를 위해 American Regent와 협력하였으며, Xeris는 제품 공급을 담당하고 American Regent는 상업화 노력을 관리합니다. 이 제품은 0.2mL 단일 용량 바이알 1mg의 1개 또는 10개 패키지로 제공될 예정이며, 시장에서의 가용성은 2025년 3분기(Q3)로 예상됩니다.
이 개발은 연간 약 2천만 건의 위장 내시경 절차가 수행되는 증가하는 절차 위장병학 시장을 겨냥하고 있습니다. 이 제품은 방사선 검사 중 성인 환자의 위장관 운동을 일시적으로 억제하도록 설계되었습니다.
Xeris Biopharma Holdings (Nasdaq: XERS) a reçu l'approbation de la FDA pour sa demande de médicament nouveau complémentaire (sNDA) pour Gvoke VialDx™, le premier glucagon liquide concentré et prêt à être dilué, utilisé comme aide diagnostique lors des examens radiologiques chez les patients adultes.
L'entreprise s'est associée à American Regent pour la commercialisation aux États-Unis, Xeris s'occupant de l'approvisionnement du produit tandis qu'American Regent gère les efforts de commercialisation. Le produit sera disponible en emballages de 1 ou 10 flacons de dose unique de 1 mg par 0,2 mL, avec une disponibilité sur le marché attendue pour le Q3 2025.
Ce développement cible le marché croissant de la gastro-entérologie procédurale, avec environ 20 millions de procédures endoscopiques gastro-intestinales réalisées chaque année. Le produit est conçu pour inhiber temporairement le mouvement du tractus gastro-intestinal chez les patients adultes lors des examens radiologiques.
Xeris Biopharma Holdings (Nasdaq: XERS) hat die Zulassung der FDA für seinen Antrag auf zusätzliche neue Arzneimittel (sNDA) für Gvoke VialDx™ erhalten, das erste konzentrierte, sofort verdünnbare flüssige Glukagon, das als diagnostische Hilfe während radiologischer Untersuchungen bei erwachsenen Patienten verwendet wird.
Das Unternehmen hat sich mit American Regent für die Vermarktung in den USA zusammengeschlossen, wobei Xeris die Produktversorgung übernimmt und American Regent die Vermarktungsmaßnahmen leitet. Das Produkt wird in 1er- oder 10er-Packungen mit 1 mg pro 0,2 ml Einzeldosis-Vials erhältlich sein, wobei die Markteinführung für Q3 2025 erwartet wird.
Diese Entwicklung zielt auf den wachsenden Markt für prozedurale Gastroenterologie ab, mit schätzungsweise 20 Millionen jährlich durchgeführten gastrointestinalen endoskopischen Verfahren. Das Produkt wurde entwickelt, um die Bewegung des Magen-Darm-Trakts bei erwachsenen Patienten während radiologischer Untersuchungen vorübergehend zu hemmen.
- FDA approval received for new diagnostic aid product
- Strategic partnership with American Regent for commercialization
- Large target market of 20 million annual procedures
- First concentrated, ready-to-dilute liquid glucagon in this space
- Product launch delayed until Q3 2025
- Financial terms of partnership not disclosed
- Multiple contraindications and safety warnings could limit market adoption
Insights
The FDA approval of Gvoke VialDx for diagnostic use represents a meaningful expansion of Xeris' glucagon franchise beyond its established hypoglycemia emergency treatment. This approval strategically diversifies revenue potential by entering the procedural gastroenterology market, estimated at
The commercialization partnership with American Regent appears well-structured, with Xeris maintaining manufacturing control while leveraging American Regent's established hospital distribution channels. This approach optimizes each company's core competencies while potentially creating a recurring revenue stream from product supply.
While financial terms remain undisclosed, this approval represents efficient R&D capital allocation by expanding applications for Xeris' existing formulation technology rather than developing entirely new compounds. The Q3 2025 commercialization timeline suggests revenue impact won't materialize until late 2025, with meaningful contribution likely in 2026.
This approval strengthens Xeris' competitive positioning in the glucagon space by establishing their formulation as the first concentrated, ready-to-dilute liquid glucagon for this indication. The strategic value extends beyond immediate revenue potential – it validates their proprietary technology platform and potentially creates opportunities for additional medical applications beyond diabetes and gastroenterology.
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 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
“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."
Joann 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.”
Gvoke VialDx will be available as a 1-count or 10-count package of 1 mg per 0.2 mL single-dose vials.
Indications and Important Safety Information
Gvoke 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.
Gvoke VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
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Gvoke and Gvoke VialDx are contraindicated in patients with:
- Pheochromocytoma because of the risk of substantial increase in blood pressure
- Insulinoma because of the risk of hypoglycemia
- Prior hypersensitivity reaction to glucagon or to any of the excipients. Serious hypersensitivity reactions have been reported with glucagon, including generalized rash, and anaphylactic shock with breathing difficulties and hypotension
- Gvoke VialDx is also contraindicated in patients with glucagonoma because of risk of hypoglycemia
- Glucagon may stimulate the release of catecholamines from the tumor. If patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate intravenously has been shown to be effective in lowering blood pressure
- In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of Gvoke or Gvoke VialDx, give glucose orally or intravenously
- Patients with insufficient hepatic stores of glycogen may not respond to Gvoke for treatment of hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia
- A skin rash called necrolytic migratory erythema (NME), has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Gvoke and Gvoke VialDx are not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks
- Gvoke VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment with Gvoke VialDx and treat hyperglycemia, if indicated
- Gvoke VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of Gvoke VialDx, and an increase in blood pressure and pulse rate may require therapy
- Gvoke VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment and monitor for changes in blood glucose during treatment
- Most common adverse reactions reported for Gvoke in adult patients were nausea, vomiting, injection site edema raised 1 mm or greater, and headache
- Most common adverse reactions reported for Gvoke in pediatric patients were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria.
- Most common adverse reactions reported for Gvoke VialDx were nausea, dysgeusia, headache, dizziness and hot flush
- Gvoke and Gvoke VialDx may increase the anticoagulant effect of warfarin; and in patients taking beta-blockers, may have a transient increase in pulse and blood pressure. In patients taking indomethacin Gvoke may lose its ability to raise glucose or may produce hypoglycemia. Concomitant use of anticholinergic drugs with Gvoke VialDx is not recommended. Monitor blood glucose when Gvoke VialDx is used in patients receiving insulin.
For full Prescribing Information, visit www.xerispharma.com.
About Xeris
Xeris (Nasdaq: XERS) is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, and a gastrointestinal motility inhibitor when used during radiology exams as a diagnostic aid; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners.
Xeris Biopharma Holdings is headquartered in
About American Regent
American Regent, Inc., a Daiichi Sankyo Group company, is an industry leading US-based pharmaceutical company. For nearly 60 years, American Regent has been developing, manufacturing and supplying quality generic and branded injectables to healthcare providers. For more than 20 years, American Regent has been a leader in IV iron therapy supplying the market with the two top-selling brands in the US. We are committed to setting a higher standard for responsiveness, reliability, and quality and helping patients live better lives by providing the essential medicines they need is the constant motivation behind everything we do, everyday. Speed counts. Flexibility matters. Reliability and quality are paramount. Because patients should never have to wait for the medications they need.
For more information, visit www.americanregent.com
Forward-Looking Statements
Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc., including the development and potential of a glucagon diagnostic product utilizing Xeris’ XeriSol™ technology, the potential for Gvoke VialDx to modernize the handling and administration of glucagon for diagnostic procedures, the expectations regarding future commercialization of Gvoke VialDx by American Regent, the timing of availability of Gvoke VialDx, Xeris’ potential entitlements to milestone and royalty payments from American Regent, the potential utility of its formulation platforms such as XeriSol™, the market and therapeutic potential of its products and product candidates, and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.
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Xeris Investor Contact
Allison Wey
Senior Vice President, Investor Relations and Corporate Communications
awey@xerispharma.com
American Regent Contact
Gennine Kelly
Sr. Director of Marketing and Portfolio Management
gkelly@americanregent.com
Source: Xeris Biopharma Holdings, Inc.
FAQ
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