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CHICAGO - Xeris Biopharma Holdings, Inc. (NASDAQ: XERS), a $742 million market cap pharmaceutical company whose stock has surged 116% over the past year, has announced the FDA approval of its supplemental new drug application for Gvoke VialDx™, intended as a diagnostic aid in radiologic examinations for adults. The company has also disclosed a partnership with American Regent for the commercialization of this new product in the United States.According to InvestingPro, Xeris maintains a "Good" financial health score, suggesting strong fundamentals supporting its growth initiatives. InvestingPro analysis reveals 8 additional key insights about the company’s potential.
Gvoke VialDx™ is designed to temporarily inhibit gastrointestinal movement during diagnostic procedures, offering a new option in the procedural gastroenterology market. The availability of Gvoke VialDx™ is expected in the third quarter of 2025.
Xeris Biopharma will be responsible for the supply of Gvoke VialDx™, while American Regent, known for its expertise in the hospital and acute care setting, will handle the commercial aspects. The financial terms of the agreement have not been made public.
Kevin McCulloch, Xeris’s President and COO, expressed enthusiasm for the FDA approval and the partnership, highlighting the potential of Gvoke VialDx™ to modernize glucagon administration for diagnostic procedures. Joann Gioia, American Regent’s Vice President and Chief Commercial Officer, echoed this sentiment, emphasizing the alignment of Gvoke VialDx™ with their mission to provide essential medicines to patients.
Gvoke VialDx™ will be offered in 1-count or 10-count packages of 1 mg per 0.2 mL single-dose vials. It is also indicated as an antihypoglycemic agent for severe hypoglycemia treatment in diabetic patients aged 2 years and older.
However, it is contraindicated for patients with conditions such as pheochromocytoma, insulinoma, and glucagonoma due to risks of severe blood pressure increase and hypoglycemia, as well as for those with prior hypersensitivity reactions to glucagon or its excipients.
The most common adverse reactions in adults and pediatric patients for Gvoke include nausea, vomiting, injection site reactions, and headache. For Gvoke VialDx™, adverse reactions reported were nausea, dysgeusia, headache, dizziness, and hot flush.
Xeris Biopharma Holdings, headquartered in Chicago, has a growing portfolio of products and continues to leverage its XeriSol® and XeriJect® technology platforms to develop new therapies.
This announcement is based on a press release statement and provides a factual summary of the FDA approval and partnership between Xeris Biopharma Holdings, Inc. and American Regent.
In other recent news, Xeris Pharmaceuticals has reported its fourth-quarter 2024 earnings, surpassing expectations with an earnings per share (EPS) of -0.03, compared to the forecasted -0.06. The company also exceeded revenue forecasts by reporting $60.1 million against the anticipated $55.99 million. This strong performance was driven by the significant growth of their products, Recorlev and Gvoke, contributing to a total revenue of $203.1 million for the year, marking a 24% increase compared to 2023. In light of these results, H.C. Wainwright raised the price target for Xeris Pharmaceuticals to $8.00 from $6.60, maintaining a Buy rating. The firm cited the company’s robust 2025 guidance, projecting revenues between $255-275 million, as a reason for the optimistic outlook. Xeris’ history of meeting or exceeding guidance has bolstered investor confidence, and the company anticipates a 30% year-over-year increase at the midpoint for 2025. Additionally, the firm highlighted the potential of Xeris’ pipeline, including the development of XP-8121, a once-weekly levothyroxine autoinjector. With a focus on expanding its prescriber base and disciplined expense management, Xeris is poised for continued growth in the endocrinology market.
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