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 Biopharma Holdings, Inc. (Nasdaq: XERS) announces the release of its fourth quarter and full year 2021 financial results on March 10, 2022, prior to U.S. market open. A conference call and webcast will follow at 8:30 a.m. ET to discuss the results. The company specializes in developing therapies for endocrinology, neurology, and gastroenterology, with products like Gvoke® and Keveyis®. Xeris also has ongoing development programs supported by proprietary formulation technologies.
Xeris Biopharma (Nasdaq: XERS) announced that its CEO, Paul R. Edick, will participate in the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022, at 12:00pm Eastern Time. The event will include a fireside chat format and will be accessible via a live webcast on the company's investor relations website. Xeris is focused on developing unique therapies in endocrinology, neurology, and gastroenterology, with products like Gvoke® for severe hypoglycemia and Recorlev® for Cushing’s syndrome, among others.
Xeris Biopharma Holdings (NASDAQ: XERS) announced that its drug Recorlev (levoketoconazole) is now exclusively available through PANTHERx Rare Specialty Pharmacy. This FDA-approved treatment for Cushing's syndrome enhances patient access through the Xeris CareConnection program, offering $0 co-pay for insured individuals and comprehensive support services. Recorlev aims to address the needs of patients unable to undergo surgery. It received positive Phase 3 study results, demonstrating significant efficacy in reducing cortisol levels.
Xeris Biopharma Holdings (NASDAQ: XERS) reported preliminary full-year 2021 pro forma net sales between
PANTHERx Rare has been chosen by Xeris Pharmaceuticals as the exclusive U.S. distribution partner for Recorlev (levoketoconazole), a newly FDA-approved treatment for endogenous hypercortisolemia in adults with Cushing's syndrome. This medication is crucial for patients for whom surgery is not viable. Cushing's syndrome is prevalent in adults aged 30-50, particularly affecting women. Recorlev will be available commercially in Q1 2022. Important safety warnings include hepatotoxicity and QT prolongation risks.
Xeris Biopharma Holdings (NASDAQ: XERS) announced that CEO Paul R. Edick will present at the H.C. Wainwright BioConnect 2022 conference from January 10-13, 2022. The presentation will highlight the FDA approval of Recorlev® and other recent company developments. It will be available on-demand starting January 10, 2022, at 7:00 a.m. E.T. Xeris specializes in therapies for endocrinology, neurology, and gastroenterology, with existing products like Gvoke® and Keveyis®. The company is headquartered in Chicago, IL.
Xeris Biopharma Holdings (NASDAQ: XERS) announced a private placement agreement with Armistice Capital, expected to close on January 3, 2022, for gross proceeds of approximately $30.0 million. The deal involves issuing 10,238,908 shares of common stock at $2.93 each and warrants to purchase an additional 5,119,454 shares at $3.223. Proceeds will be allocated to operational support, product marketing, clinical trials, and general corporate purposes. The shares will not be registered under the Securities Act upon issuance and will require a resale registration statement.
Xeris Biopharma announced FDA approval for Recorlev (levoketoconazole), a treatment for Cushing's syndrome in adults where surgery isn't an option. The decision follows the acquisition of Strongbridge Biopharma on October 5, 2021. Safety and efficacy were supported by positive results from two pivotal Phase 3 studies (SONICS and LOGICS) involving 166 patients. A commercial launch is planned for Q1 2022, positioning Xeris to meet the treatment needs of this patient population.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) announced the UK launch of Ogluo® (glucagon injection) through its commercialization partner, Tetris Pharma, for treating severe hypoglycemia in diabetes patients aged 2 and over. This follows a licensing deal in July for Ogluo's commercialization in the UK and EU. Xeris estimates around 5 million people in the UK are at risk of severe hypoglycemia, with only 10-20% currently prescribed glucagon. The launch aims to increase accessibility and provide a ready-to-use solution for emergencies.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) reported strong third-quarter performance with pro forma net sales of $22.5 million, driven by Gvoke and Keveyis, expected to reach $76-$80 million for 2021. The acquisition of Strongbridge Biopharma was finalized on October 5, 2021, with integration completed and $50 million in synergies anticipated. The company boasts a robust cash position of approximately $100 million at year-end, along with a 12-month extension on its debt facility, pushing principal repayments to 2023.
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