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 (Nasdaq: XERS) announces a significant milestone for Gvoke, a ready-to-use glucagon treatment for severe hypoglycemia, achieving extensive payor coverage. Approximately 91% of Medicare patients and 88% of commercially insured patients now have unrestricted access to Gvoke. The company emphasizes its commitment to affordable healthcare and effective market access strategies. The press release highlights the importance of ensuring access for patients, especially with children returning to school. Gvoke was FDA-approved in September 2019, and it is crucial for diabetes management.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced the FDA's approval of its Investigational New Drug Application (IND) for XeriSol levothyroxine, enabling the initiation of a Phase 1 clinical study for XP-8121. This study will assess the pharmacokinetics, safety, and tolerability of XeriSol's subcutaneous levothyroxine treatment for hypothyroidism. The company aims to address unmet needs in oral levothyroxine therapy by offering weekly subcutaneous injections to improve patient compliance and mitigate existing treatment challenges.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced its Q2 financial results for 2021, showcasing a 32% increase in Gvoke net sales, totaling $8.8 million. The company reported a net loss of $27.5 million, improving from a loss of $24.1 million in Q2 2020. The proposed acquisition of Strongbridge Biopharma is anticipated to close in Q4 2021, with a cash position of $116 million. Gvoke's prescription volume surged, reaching over 21,000, and a partnership with Tetris Pharma aims to commercialize Ogluo in Europe, potentially adding up to $71 million in future payments.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) reported its issued share capital as of July 28, 2021, consisting of 66,497,370 shares of common stock. The company also noted 5,081,323 stock options, 2,059,762 restricted stock units, 94,012 warrants, and $47,175,000 in convertible notes due 2025. Xeris, known for its innovative injectable therapeutic solutions, has technologies that improve the ease and stability of drug administration, including its commercial product, Gvoke®. The announcement also highlights upcoming SEC filings related to the acquisition of Strongbridge Biopharma.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) will release its second quarter 2021 financial results on August 5, 2021, before the U.S. market opens. A conference call will be held at 8:30 a.m. ET to discuss financial and operational results. Xeris specializes in ready-to-use injectable formulations, with its proprietary technologies such as XeriSol™ and XeriJect™, aimed at simplifying administration and enhancing stability. The company's first commercial product is Gvoke®. Investors can register for the call and access a replay later.
Xeris Pharmaceuticals (Nasdaq: XERS) announced executive changes to strengthen its commercial strategy, particularly ahead of the acquisition of Strongbridge Biopharma. CFO Barry Deutsch has stepped down but will assist during the transition until the merger's expected completion in Q4 2021. Steven Pieper, with 20 years of healthcare finance experience, has been promoted to CFO. He previously helped launch Xeris's first commercial product, Gvoke®. The company continues to focus on innovative, ready-to-use injectable drug formulations to enhance patient care.
Xeris Pharmaceuticals (Nasdaq: XERS) has entered an exclusive agreement with Tetris Pharma for the commercialization of Ogluo® in the European Economic Area, the UK, and Switzerland, aimed at treating severe hypoglycaemia in diabetes patients. Xeris is set to receive up to $71 million in milestone payments and royalties on net sales. The partnership is expected to enhance Ogluo's accessibility to insulin-dependent diabetes patients, where the demand is significant, yet current glucagon prescriptions remain low.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) disclosed that on July 1, 2021, it granted 80,250 restricted stock units to 37 new employees through its Inducement Equity Plan. This plan targets new hires as incentives for accepting employment. The stock options will vest over four years, with various vesting schedules based on employment duration. Xeris specializes in ready-to-use injectable formulations, aiming to simplify medication delivery and reduce healthcare costs. Its proprietary technologies, XeriSol™ and XeriJect™, enhance stability and ease of use for patients and providers.
Xeris Pharmaceuticals (XERS) has announced an agreement to acquire Strongbridge Biopharma (SBBP) for approximately $267 million in stock and contingent value rights (CVRs). Strongbridge shareholders will receive a fixed exchange ratio of 0.7840 shares of the new entity, Xeris Biopharma Holdings, and potential CVRs based on sales milestones of KEVEYIS® and RECORLEV®. This merger aims to create a diversified biopharmaceutical company focused on rare diseases, enhancing revenue growth with commercial assets like Gvoke® and RECORLEV®. The transaction is expected to close in Q4 2021.
Xeris Pharmaceuticals (XERS) announced its acquisition of Strongbridge Biopharma (SBBP) for approximately $267 million, combining their operations into Xeris Biopharma Holdings. Strongbridge shareholders will receive 0.7840 shares of Xeris for each of their shares, translating to about $2.72 per share, a 12.9% premium. Contingent value rights (CVRs) could add up to $1.00 per share based on sales targets for KEVEYIS and RECORLEV. Post-acquisition, current Xeris shareholders will hold 60% of the company.
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