Welcome to our dedicated page for Xeris Biopharma Holdings news (Ticker: XERS), a resource for investors and traders seeking the latest updates and insights on Xeris Biopharma Holdings stock.
Overview
Xeris Biopharma Holdings Inc (XERS) is a biopharmaceutical company that specializes in developing and commercializing innovative, ready-to-use biotherapeutics. The company is distinguished by its deep expertise in formulation science and biotherapeutic development, with a unique focus on addressing challenging conditions in the fields of endocrinology, neurology, and gastroenterology. By leveraging proprietary technologies such as XeriSol and XeriJect, Xeris aims to simplify treatment administration and improve patient outcomes through ultra-low volume injectable devices and patient-friendly formulations.
Core Technologies and Product Portfolio
Central to Xeris Biopharma’s mission is the use of breakthrough formulation science. The company’s proprietary technologies have been instrumental in creating products that stand out for their ease of use and direct applicability to clinical needs. XeriSol focuses on innovative formulation strategies while XeriJect has paved the way for ultra-low volume injectable devices that potentially mitigate the discomfort of traditional injection methods. This technological edge supports a portfolio that is uniquely positioned to serve patient populations requiring precise, efficient, and less invasive therapeutic solutions.
Commercial Products
Xeris has successfully brought several therapies to market that address critical conditions with new methods of administration. The product Gvoke offers ready-to-use liquid glucagon, designed for the rapid treatment of severe hypoglycemia, thereby ensuring swift and reliable relief during emergencies. Keveyis, another milestone, is recognized as the first FDA-approved therapy intended for primary periodic paralysis, marking a significant advancement in neuromuscular treatment options. Additionally, Recorlev provides an FDA-approved treatment for endogenous hypercortisolemia in adults with Cushing's Syndrome. Each of these commercial products not only meets specific therapeutic needs but also exemplifies the company’s commitment to refining drug delivery through advanced biotherapeutic formulations.
Innovative Pipeline and Formulation Science
Beyond its existing market offerings, Xeris Biopharma has a robust pipeline of development programs aimed at expanding its footprint in the biotherapeutic landscape. The company’s ongoing research utilizes its own formulation platforms to address unmet clinical needs. By continuously focusing on innovation in drug formulation and injectable delivery, Xeris demonstrates an unwavering commitment to pushing the boundaries of conventional treatment methodologies. Its efforts in refining ultra-low volume, ready-to-use biotherapeutics provide a strategic advantage, potentially alleviating the challenges associated with traditional injection therapies for hundreds of millions of patients.
Market Position and Competitive Landscape
Operating within the competitive arena of biopharmaceuticals, Xeris Biopharma holds a distinct niche due to its focus on patient-friendly, ready-to-use biotherapeutics. Its targeted approach in addressing conditions related to endocrinology, neurology, and gastroenterology distinguishes it from more traditional pharmaceutical companies. Positioned in a sector that demands constant innovation and a careful balance of safety and efficacy, Xeris has integrated rigorous formulation science with practical clinical applications, thus reinforcing its reputation as a company grounded in deep technical expertise and clinical insight.
Patient-Centric Approach and Value Proposition
The company’s innovative approach is underscored by its commitment to enhancing the treatment experience for patients. By developing therapies that are not only clinically effective but also easier to administer, Xeris focuses on lowering the barriers to treatment adherence. The incorporation of patient-friendly injectable devices, designed to ease the discomfort commonly associated with injections, speaks to a broader vision of improved quality of life. This patient-centric perspective is woven into every facet of the company’s operations, ensuring that every product is developed with the end-user’s comfort and convenience in mind.
Operational Excellence and Regulatory Rigor
Xeris Biopharma operates in an environment where compliance and clinical precision are paramount. The company’s products have undergone and continue to meet stringent regulatory standards, assuring stakeholders of both safety and efficacy. Through a disciplined regulatory strategy and a commitment to high-quality manufacturing practices, Xeris reinforces its position as a trusted entity in the formulation and delivery of biotherapeutics. This adherence to strict quality control further enhances the reliability of its products, establishing a strong foundation for long-term credibility in an increasingly competitive field.
Conclusion
In summary, Xeris Biopharma Holdings Inc presents a compelling case study in the integration of advanced formulation science with practical biotherapeutic applications. Its commercial products, such as Gvoke, Keveyis, and Recorlev, exemplify its ability to address diverse patient needs effectively. Supported by proprietary technologies like XeriSol and XeriJect, the company’s approach highlights a strategic blend of innovation, patient focus, and operational rigor. Through its commitment to developing ultra-low volume, ready-to-use therapies, Xeris continues to enhance treatment options within endocrinology, neurology, and gastroenterology, providing a clear reflection of expertise and a steadfast commitment to improved patient outcomes.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) has received European Commission approval for Ogluo™ (glucagon) injection, aimed at treating severe hypoglycemia in diabetes patients aged 2 years and above. This marketing authorization covers all 27 EU countries, along with Iceland, Norway, and Liechtenstein. Xeris plans to launch Ogluo later this year, while also seeking commercialization partnerships to expand availability. The approval stems from a Phase 3 study showing comparable efficacy to Novo Nordisk’s GlucaGen HypoKit, with no major safety concerns noted.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced the grant of 16,000 non-qualified stock options to 38 new employees as part of its Inducement Equity Plan on January 27, 2021. This plan is designed to attract individuals not previously employed by Xeris, with options vesting over four years based on continued employment. Xeris specializes in developing ready-to-use injectable and infusible drug formulations through its advanced technology platforms, offering potential cost-saving and user-friendly solutions in the pharmaceutical market.
Xeris Pharmaceuticals (Nasdaq: XERS) announced that CEO Paul R. Edick will present at the H.C. Wainwright BioConnect 2021 virtual conference from January 11-14, 2021. The presentation will provide an overview of the company's innovative drug technologies, including its proprietary XeriSol™ and XeriJect™ platforms that offer stable, ready-to-use formulations. A webcast will be available starting January 11 at 6:00 a.m. E.T. on the company's website.
Xeris aims to simplify administration of vital therapies, benefiting patients and healthcare systems.
Xeris Pharmaceuticals, Inc. (NASDAQ: XERS) announced the grant of non-qualified stock options for 38,250 shares and restricted stock units for 35,100 shares to 7 new employees under its Inducement Equity Plan as of December 30, 2020. The options will vest over four years, either with 25% vesting after one year or 36% after 18 months, while the restricted stock units will vest in equal annual installments. This plan aims to incentivize new hires in line with NASDAQ Listing Rules. Xeris focuses on developing ready-to-use injectable medications using advanced formulation technologies.
Xeris Pharmaceuticals (Nasdaq: XERS) has entered an exclusive distribution agreement with Megapharm Ltd. for the commercialization of its Gvoke® (glucagon injection) in Israel and the Palestinian Authority. Gvoke® is recognized as the world's first ready-to-use liquid glucagon for treating severe hypoglycemia in diabetes patients aged 2 and above. Megapharm will oversee product registration and marketing, while Xeris manages manufacturing and regulatory support. Gvoke® is expected to be available in Israel in 2022, with early access for named patients starting in early 2021.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) received a positive Opinion from the European Medicines Agency’s CHMP for Ogluo™ (glucagon) for treating severe hypoglycemia in diabetes patients. A final decision on the Marketing Authorization Application is expected in Q1 2021. If approved, Ogluo could launch in select European countries in the latter half of 2021. The positive recommendation is based on a Phase 3 study showing comparable efficacy to Novo Nordisk’s GlucaGen® HypoKit®. The study involved 132 adults with type 1 diabetes, indicating no significant safety concerns.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced the granting of stock options and restricted stock units to 11 new employees under its Inducement Equity Plan. On November 25, 2020, a total of 18,000 stock options and 70,200 restricted stock units were awarded, which vest over four years contingent on continued employment. This plan, designed for new hires, aims to attract and retain talent while adhering to NASDAQ rules. Xeris specializes in developing ready-to-use injectable and infusible therapies aimed at simplifying patient administration.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) reported financial results for Q3 2020, noting a net loss of $16 million ($0.35 per share), an improvement from a loss of $32.8 million in Q3 2019. Gvoke, a ready-to-use glucagon auto-injector, achieved $9.4 million in sales for the quarter, showing a 140% increase in prescriptions. R&D expenses decreased to $3.9 million, while SG&A rose to $16.5 million due to increased personnel costs. As of September 30, 2020, Xeris had $141.7 million in cash. The company anticipates key regulatory decisions in 2021.
Xeris Pharmaceuticals (Nasdaq: XERS) will release its Q3 2020 financial results on November 9, 2020, prior to the U.S. market opening. A conference call will follow at 8:30 a.m. ET to discuss financial and operational outcomes. As a specialty pharmaceutical company, Xeris focuses on innovative drug formulations to improve therapy administration. Notably, its proprietary platforms provide room-temperature stable injectable therapies, streamlining use for patients and healthcare providers.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) has granted non-qualified stock options totaling 36,250 shares to 15 new employees as part of its Inducement Equity Plan. This plan provides equity awards to individuals not previously employed by Xeris, incentivizing them to join the company. The stock options will vest over four years, with various vesting schedules based on continued employment. Xeris leverages innovative technology to simplify injectable and infusible drug formulations, with its first commercial product being Gvoke®.
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