Xeris Biopharma Holdings, Inc. reports news about its commercial biopharmaceutical business, including product revenue, financial guidance and operating updates tied to Recorlev®, Gvoke® and Keveyis®. The company commercializes Recorlev for endogenous Cushing’s syndrome, Gvoke ready-to-use liquid glucagon for severe hypoglycemia and Keveyis for primary periodic paralysis.
Recurring updates also cover development of XP-8121, a Phase 3-ready once-weekly subcutaneous levothyroxine candidate for hypothyroidism, and programs using Xeris’ XeriSol® and XeriJect® technology platforms. Company news includes intellectual property developments for Recorlev, partnership-related revenue, and equity inducement grants under Nasdaq listing rules.
Xeris Pharmaceuticals (NASDAQ: XERS) announced the successful enrollment and dosing of participants in a Phase 1 study of XP-8121, a novel subcutaneous formulation of levothyroxine for hypothyroidism. This study aims to evaluate pharmacokinetics, safety, and tolerability, with results expected in Q1 2022. Preliminary data suggest XP-8121 may overcome challenges associated with oral levothyroxine, such as dosage variability and medication adherence. The study involves 30 healthy participants and is conducted in partnership with Celerion.
Xeris Pharmaceuticals (Nasdaq: XERS) announced the FDA approval of its supplemental new drug application (sNDA) for the Gvoke® Kit, a ready-to-use injectable drug formulation for treating severe hypoglycemia in diabetes patients aged 2 and above. The Gvoke Kit will include a 1 mg/0.2 mL single-dose vial and syringe kit, enhancing patient convenience by eliminating the need for reconstitution. Manufacturing will commence immediately, with availability expected early in Q1 2022. The approval was backed by a pharmacokinetic study showing bioequivalence to the pre-filled syringe formulation.
Xeris Pharmaceuticals (Nasdaq: XERS) has announced the grant of three new patents concerning its formulation technologies. The U.S. Patent and Trademark Office issued U.S. Patent Nos. 10,987,399 and 11,020,403, covering storage-stable formulations of pramlintide and benzodiazepines, respectively. Additionally, the China Intellectual Property Office granted Chinese Patent No. ZL201580042185.5 for pre-filled syringes utilizing Xeris’ XeriJect™ technology. These patents expand Xeris’ intellectual property portfolio, now totaling 121 patents worldwide, supporting innovation in therapies for diabetes and other conditions.
Xeris Pharmaceuticals (Nasdaq: XERS) announces a significant milestone for Gvoke, a ready-to-use glucagon treatment for severe hypoglycemia, achieving extensive payor coverage. Approximately 91% of Medicare patients and 88% of commercially insured patients now have unrestricted access to Gvoke. The company emphasizes its commitment to affordable healthcare and effective market access strategies. The press release highlights the importance of ensuring access for patients, especially with children returning to school. Gvoke was FDA-approved in September 2019, and it is crucial for diabetes management.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced the FDA's approval of its Investigational New Drug Application (IND) for XeriSol levothyroxine, enabling the initiation of a Phase 1 clinical study for XP-8121. This study will assess the pharmacokinetics, safety, and tolerability of XeriSol's subcutaneous levothyroxine treatment for hypothyroidism. The company aims to address unmet needs in oral levothyroxine therapy by offering weekly subcutaneous injections to improve patient compliance and mitigate existing treatment challenges.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) announced its Q2 financial results for 2021, showcasing a 32% increase in Gvoke net sales, totaling $8.8 million. The company reported a net loss of $27.5 million, improving from a loss of $24.1 million in Q2 2020. The proposed acquisition of Strongbridge Biopharma is anticipated to close in Q4 2021, with a cash position of $116 million. Gvoke's prescription volume surged, reaching over 21,000, and a partnership with Tetris Pharma aims to commercialize Ogluo in Europe, potentially adding up to $71 million in future payments.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) reported its issued share capital as of July 28, 2021, consisting of 66,497,370 shares of common stock. The company also noted 5,081,323 stock options, 2,059,762 restricted stock units, 94,012 warrants, and $47,175,000 in convertible notes due 2025. Xeris, known for its innovative injectable therapeutic solutions, has technologies that improve the ease and stability of drug administration, including its commercial product, Gvoke®. The announcement also highlights upcoming SEC filings related to the acquisition of Strongbridge Biopharma.
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) will release its second quarter 2021 financial results on August 5, 2021, before the U.S. market opens. A conference call will be held at 8:30 a.m. ET to discuss financial and operational results. Xeris specializes in ready-to-use injectable formulations, with its proprietary technologies such as XeriSol™ and XeriJect™, aimed at simplifying administration and enhancing stability. The company's first commercial product is Gvoke®. Investors can register for the call and access a replay later.
Xeris Pharmaceuticals (Nasdaq: XERS) announced executive changes to strengthen its commercial strategy, particularly ahead of the acquisition of Strongbridge Biopharma. CFO Barry Deutsch has stepped down but will assist during the transition until the merger's expected completion in Q4 2021. Steven Pieper, with 20 years of healthcare finance experience, has been promoted to CFO. He previously helped launch Xeris's first commercial product, Gvoke®. The company continues to focus on innovative, ready-to-use injectable drug formulations to enhance patient care.
Xeris Pharmaceuticals (Nasdaq: XERS) has entered an exclusive agreement with Tetris Pharma for the commercialization of Ogluo® in the European Economic Area, the UK, and Switzerland, aimed at treating severe hypoglycaemia in diabetes patients. Xeris is set to receive up to $71 million in milestone payments and royalties on net sales. The partnership is expected to enhance Ogluo's accessibility to insulin-dependent diabetes patients, where the demand is significant, yet current glucagon prescriptions remain low.