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.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS) is a biopharmaceutical company headquartered in Chicago, Illinois, with a commercial portfolio and pipeline focused on endocrine and neurological conditions. News about Xeris frequently centers on the performance of its three marketed products—Recorlev, Gvoke, and Keveyis—as well as updates on its lead pipeline candidate, XP-8121, and its proprietary XeriSol and XeriJect formulation platforms.
Investors following XERS news can expect regular coverage of quarterly and full-year financial results, including product-level revenue for Recorlev, Gvoke, and Keveyis, trends in patient demand, and commentary on profitability metrics such as Adjusted EBITDA. The company’s press releases and accompanying Form 8-K filings provide detailed breakdowns of revenue, costs, and operating performance, along with management’s discussion of strategic priorities.
Xeris news flow also includes announcements related to intellectual property, such as Orange Book listings and patent notices for Recorlev and XP-8121, as well as partnership updates like the agreement with American Regent for the commercialization of Gvoke VialDx in the United States. Additional items may cover analyst and investor events, revenue guidance updates, and long-term outlooks that management shares with the market.
For those tracking developments in Xeris’ pipeline, news items highlight regulatory milestones, patent allowances, and R&D investment in XP-8121 and other early-stage programs using XeriSol and XeriJect. By monitoring this news page, readers can review a chronological record of Xeris’ operational, financial, and strategic announcements as they are released.
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.
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.