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) has announced it will release its fourth-quarter and full-year 2022 financial results on March 8, 2023, before market open. Following this, management will host a conference call and webcast at 8:30 a.m. ET to discuss the outcomes. Xeris focuses on developing innovative biopharmaceutical products, including Gvoke®, Keveyis®, and Recorlev®. The company aims to enhance patient lives through differentiated therapies and has a diverse pipeline leveraging its proprietary formulation sciences, XeriSol™ and XeriJect™.
Xeris Biopharma, Inc. (Nasdaq: XERS) announced its participation in the SVB Securities Global Biopharma Conference 2023, scheduled for February 15, 2023, from 10:40 to 11:10 am ET. Senior management will conduct 1x1 investor meetings and provide a company overview. Investors can access the audio webcast on the company's website. Xeris is focused on developing innovative biopharmaceutical products, including Gvoke® for severe hypoglycemia, Keveyis® for primary periodic paralysis, and Recorlev® for Cushing's syndrome. The company utilizes proprietary formulation platforms, XeriSol™ and XeriJect™, to enhance its product pipeline.
Xeris Biopharma Holdings (Nasdaq: XERS) has received orphan-drug exclusivity for Recorlev® (levoketoconazole) from the FDA, marking it as the first approved treatment for endogenous Cushing’s syndrome. This exclusivity provides Xeris a seven-year market advantage following its December 30, 2021, approval. Recorlev is indicated for adult patients unable to undergo surgery or where surgery has failed. The approval is based on successful Phase 3 trials involving 166 patients, demonstrating significant efficacy in cortisol reduction. Xeris emphasizes its commitment to supporting patients through comprehensive programs like Xeris CareConnection.
Xeris Biopharma Holdings (Nasdaq: XERS) announced that CEO Paul R. Edick will present at the 41st Annual J.P. Morgan Healthcare Conference on January 12, 2023, at 12:00 PM PT. Interested parties can access the presentation on the company's investor relations page. Xeris focuses on developing innovative biopharmaceutical products, including Gvoke®, Keveyis®, and Recorlev®. The company also leverages advanced formulation technology platforms, XeriSol™ and XeriJect™, to enhance therapeutic options for patients.
Xeris Biopharma Holdings (Nasdaq: XERS) expects to conclude 2022 with over
Xeris Biopharma Holdings (Nasdaq: XERS) announced plans to initiate a Phase II study in the second half of 2023 for a novel formulation of levothyroxine sodium (SC injection) as replacement therapy for hypothyroidism. This decision follows positive feedback from an FDA Type C meeting regarding the clinical plan for a once-weekly subcutaneous formulation. The Phase II study aims to assess the average dosing and chronic safety data. The company had previously reported positive Phase I data, indicating safety and effective absorption profiles compared to current treatments.
Xeris Biopharma Holdings (XERS) has partnered with Horizon Therapeutics (HZNP) to develop an ultra-concentrated, ready-to-use subcutaneous injection of teprotumumab, FDA-approved for Thyroid Eye Disease. The agreement utilizes Xeris' proprietary XeriJect technology, enhancing patient treatment experience. Xeris will receive an upfront payment and may earn additional milestone payments and royalties if the technology is licensed. This collaboration aims to improve drug delivery and patient adherence. No specific financial terms were disclosed.
Xeris Biopharma achieved record net product revenue of $29.6 million in Q3 2022, a 17% increase from Q2 2022 and a 31% increase year-over-year on a pro forma basis. The company tightened its full-year revenue guidance to $105M-$110M and raised year-end cash balance guidance to $110M-$120M. Notable revenue drivers included Gvoke with $13.7 million and Keveyis with $13.4 million. The firm reported positive results from its Phase 1 study of XP-8121 and published findings on Recorlev in the European Journal of Endocrinology.
Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) announced the release of its third quarter 2022 financial results on November 9, 2022, before U.S. market open. The company will host a conference call at 8:30 a.m. ET on the same day to discuss financial and operational outcomes. Xeris focuses on innovative biopharmaceutical products, including Gvoke® for severe hypoglycemia, Keveyis® for primary periodic paralysis, and Recorlev® for Cushing’s syndrome. The company aims to extend current products to new indications and develop new therapies through proprietary formulation technologies.
Xeris Biopharma Holdings (NASDAQ: XERS) announced positive results from the extended evaluation of its SONICS study, evaluating levoketoconazole for treating Cushing's syndrome. The study showed sustained cortisol level reductions and quality of life improvements over a median treatment duration of 15 months. Notably, 46 patients completed the study with only a 6.7% discontinuation rate due to adverse events. Levoketoconazole demonstrated safety with no new drug-related signals. The treatment continues to support its role in managing this rare but serious endocrine disease.
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