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 (XERS) announced positive topline results from its Phase 1 study of XP-8121, a novel subcutaneous levothyroxine formulation. This study, involving 60 healthy adults, showed that XP-8121 provides similar pharmacokinetics to daily oral Synthroid, offering a potential once-weekly dosing option. The data suggests that a 1200 μg SC dose of XP-8121 could correspond to a 300 μg dose of Synthroid, indicating a 4X dose conversion factor. The treatment was well tolerated, and the company expects FDA feedback by year-end.
Xeris Biopharma achieved record net product revenue of $25.3 million for Q2 2022, reflecting a 15% increase from Q1 2022 and a 34% increase year-over-year on a pro forma basis. The company ended Q2 with $111.6 million in cash and investments, reaffirming a full-year revenue guidance of $105 million to $120 million. Key products such as Gvoke and Keveyis reported strong performances, with Gvoke growing by 30% to $11.5 million in revenue. However, net losses were reported at $26.2 million for the quarter.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) will release its second quarter 2022 financial results on August 10, 2022, before U.S. market open. A conference call will follow at 8:30 a.m. ET to discuss the results. The company focuses on developing innovative therapies, with three products currently available: Gvoke®, Keveyis®, and Recorlev®. Xeris aims to expand its product pipeline through proprietary formulation technologies.
Xeris Biopharma Holdings (Nasdaq: XERS) announced that its commercialization partner, Tetris Pharma, will be acquired by Arecor Therapeutics, contingent upon Arecor's successful capital offering. Upon completion, Arecor is set to continue the commercialization of Ogluo in the UK and EEA. The acquisition aims to leverage Arecor's resources to enhance the marketing of Ogluo, a glucagon treatment for severe hypoglycemia in diabetes patients. Xeris will still be responsible for product supply and anticipates a smooth transition of commercial activities.
Xeris Biopharma Holdings (NASDAQ: XERS) presented new findings on Cushing's syndrome (CS) at the AACE Annual Meeting held from May 12-14, 2022. Key highlights include the LOGICS study, a phase 3 trial showing that patients on placebo had a significantly worse mean urinary-free cortisol (mUFC) response than those on Recorlev® (levoketoconazole). Additionally, a burden of illness study indicated that CS patients report moderate impairment in health-related quality of life, with 89% using over-the-counter analgesics for symptom relief. No new safety signals for Recorlev were identified during the study.
Xeris Biopharma Holdings reported Q1 2022 net product revenue of $21.9M, reflecting a 33% increase year-over-year on a pro forma basis. The company ended the quarter with $132.1M in cash and equivalents, affirming 2022 revenue guidance of $105M - $120M and aiming for cash flow breakeven by year-end 2023. Key products like Gvoke achieved over 30,000 prescriptions, a growth of 88%. However, net loss for the quarter stood at $33.7M, compared to $18.4M in Q1 2021.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) will announce its first quarter 2022 financial results before the U.S. market opens on May 11, 2022. A conference call and webcast will follow at 8:30 a.m. ET for investors to discuss the results. Xeris specializes in unique therapies for endocrinology, neurology, and gastroenterology, with three available products: Gvoke®, Keveyis®, and Recorlev®. The company aims to expand its pipeline with novel treatments utilizing its proprietary formulation technologies.
Xeris Biopharma Holdings (Nasdaq: XERS) announced the availability of the Gvoke® Kit, a ready-to-use glucagon injection for severe hypoglycemia, now accessible by prescription. This kit includes a single-dose sterile syringe and vial, designed for those at risk of low blood sugar events. The Gvoke products received FDA approval in September 2019 and August 2021. The company, headquartered in Chicago, aims to meet the growing demand among patients to keep Gvoke readily available for emergencies.
Xeris Biopharma Holdings (XERS) completed the acquisition of Strongbridge Biopharma, realizing $50M in synergies by year-end 2022. Pro forma net product revenues rose to $79M in FY '21, a 56% increase. Expected growth for 2022 is $105M-$120M with cash resources projected at $90M-$110M by year-end. The company anticipates reaching cash flow breakeven by the end of 2023. Key product sales, including Gvoke and Recorlev, are driving growth, alongside a strong cash position bolstered by recent financing moves.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) has secured a $150 million senior secured term loan from Hayfin Capital Management. The initial drawdown of $100 million will repay existing debts and enhance working capital. Xeris aims for cash flow breakeven by year-end 2023, leveraging a total capital base of approximately $180 million. The debt facility has a five-year maturity with a 9% interest rate and provides additional borrowing flexibility. Xeris' CFO noted this agreement increases financial strength while protecting shareholder interests through non-dilutive capital.
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