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Xeris Biopharma Holdings, Inc. (Symbol: XERS) is a pioneering biopharmaceutical company committed to developing and commercializing innovative therapies for patient populations in endocrinology, neurology, and gastroenterology. The company's mission is to revolutionize patient care by creating ultra-low volume, ready-to-use biotherapeutics delivered through patient-friendly injectable devices.
Xeris has successfully brought three groundbreaking products to market:
- Gvoke: A ready-to-use liquid glucagon designed to treat severe hypoglycemia, providing a critical solution for diabetic patients.
- Keveyis: The first FDA-approved therapy for primary periodic paralysis, offering relief for those suffering from this rare genetic disorder.
- Recorlev: Approved by the FDA for the treatment of endogenous hypercortisolemia in adult patients with Cushing's Syndrome, addressing a previously unmet need in this patient population.
In addition to these commercial successes, Xeris continues to innovate with a robust pipeline of development programs. Utilizing its proprietary formulation technologies, XeriSol and XeriJect, the company aims to bring new therapies to market that ease the administration and increase the efficacy of injectable treatments.
Financially, Xeris Biopharma Holdings has shown significant growth and resilience in a competitive market. Their strategic partnerships and collaborations further bolster their developmental and commercial capabilities, ensuring a steady pipeline of innovative products aimed at improving patient outcomes.
Recent achievements and ongoing projects underline Xeris' commitment to enhancing the quality of life for millions of patients globally. Keep up with the latest updates and news about Xeris Biopharma Holdings, Inc. to stay informed about their ongoing advancements and performance in the biopharmaceutical industry.
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.
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.