Articles from Xeris Pharmaceuticals, Inc.

Xeris Pharmaceuticals, Inc., a wholly owned subsidiary of Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that today the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance with respect to U.S. Patent Application No. 17/151,405, entitled “Compositions and Methods of Use.” The allowed claims in this application cover the use of the company’s KEVEYIS® (dichlorphenamide) product. The Notice of Allowance indicates that the USPTO has determined that the application meets the requirements for patentability and is expected to issue as a U.S. patent following the completion of standard administrative steps. Following this issuance, the Company will submit the patent to the U.S. Food and Drug Administration (FDA) for listing in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the Orange Book. Assuming that all necessary actions are taken and all maintenance fees are paid, this new patent will provide intellectual property protection for KEVEYIS through 2039.

Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, and Xeris Pharmaceuticals, Inc., today announced financial results for the third quarter and first nine months ended September 30, 2021, and recent highlights, including the completion of the Strongbridge Biopharma plc acquisition on October 5, 2021.

Xeris Pharmaceuticals, Inc. (“Xeris”), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that it has successfully completed the previously announced acquisition of Strongbridge Biopharma plc (Nasdaq: SBBP) (“Strongbridge”). Under the terms of the acquisition agreement, the businesses of Xeris and Strongbridge are now combined under Xeris Biopharma Holdings, Inc. (“Xeris Biopharma Holdings”). Strongbridge shares and Xeris shares ceased trading on the Nasdaq Global Select Market (“Nasdaq”) at the close of business today. Shares of Xeris Biopharma Holdings are expected to begin trading on the Nasdaq under the ticker symbol “XERS” on October 6, 2021.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that on October 1, 2021, the Compensation Committee of Xeris’ Board of Directors granted restricted stock units for an aggregate of 28,750 shares of its common stock to 20 new employee(s) under Xeris’ Inducement Equity Plan.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals, will present an overview of the Company at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on Wednesday, September 22, 2021, at 8:15 a.m. Eastern Time. The presentation can be accessed by visiting ‘Upcoming Events’ on the Company's website at www.xerispharma.com.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) (“Xeris”) today announced that its stockholders have voted to approve the previously announced proposed acquisition of Strongbridge Biopharma plc (NASDAQ: SBBP) (“Strongbridge”) by Xeris.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals, will present an overview of the Company during the H.C. Wainwright 23rd Annual Global Investment Conference held virtually this year from September 13-15, 2021.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that the company has completed enrollment and successfully dosed all participants in a Phase 1 study of levothyroxine (XP-8121) to evaluate the pharmacokinetics, safety and tolerability, and potential for weekly dosing of the investigational, novel, subcutaneous (SC) injection for the treatment of hypothyroidism.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) today announced that a leading independent proxy advisory firm Institutional Shareholder Services (“ISS”) has recommended that Xeris stockholders vote “FOR” all proposals related to the Company’s transaction with Strongbridge Biopharma plc (Nasdaq: SBBP) (“Strongbridge”).

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Gvoke Kit will be available as a 1 mg/0.2 mL single dose vial and syringe kit. Gvoke Kit contains one (1) single-dose sterile syringe with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution. With this FDA approval, Xeris will begin manufacturing scale up immediately, and therefore anticipates Gvoke Kit availability early in the first quarter of 2022.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that it has recently been granted three new patents relating to its formulation technology platforms. The U.S. Patent and Trademark Office granted U.S. Patent Nos. 10,987,399 and 11,020,403 to Xeris, and the China Intellectual Property Office granted Chinese Patent No. ZL201580042185.5 to Xeris. The US ‘399 patent covers storage-stable formulations of pramlintide, and the US ‘403 patent covers storage-stable formulations of benzodiazepines, both using Xeris’ proprietary XeriSol™ formulation technology. The Chinese ’185.5 patent covers pre-filled syringes containing a variety of active pharmaceutical ingredients, using Xeris’ proprietary XeriJect™ technology. These patents, and related patent applications that are pending in these and other patent offices around the world, also cover the uses of such products in treating a variety of diseases and disorders including diabetes.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced the achievement of an important milestone of payor coverage for Gvoke – a ready-to-use glucagon for the treatment of severe hypoglycemia for adults and children with diabetes ages 2 and above. Today, approximately 91% of Medicare patients, 88% of commercially insured patients, and a growing number of Medicaid lives have unrestricted access to Gvoke.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the Food and Drug Administration (FDA) has allowed the Investigational New Drug Application (IND) for its XeriSol levothyroxine for hypothyroidism to proceed. The active IND enables Xeris to initiate a Phase 1 clinical study for XP-8121 using its novel formulation of levothyroxine in a subcutaneous injection for the treatment of hypothyroidism. The Phase 1 study will characterize Pharmacokinetics (PK) and evaluate the safety and tolerability of XP-8121 in healthy participants.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced financial results for the second quarter and first six months ended June 30, 2021, and recent highlights.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) (Xeris) today announced in accordance with Rule 2.10 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013 (the Irish Takeover Rules) that, as of the close of business on July 28, 2021, Xeris' issued share capital, excluding treasury shares, is comprised of 66,497,370 shares of common stock with a par value of $0.0001 per share. Xeris' common stock is traded on the Nasdaq Global Select Market under the symbol XERS. The International Securities Identification Number (ISIN) of Xeris common stock is US98422L1070.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that the Company will release its second quarter 2021 financial results before the open of the U.S. financial markets on Thursday, August 5, 2021. Management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the Company’s financial and operational results.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced executive changes as part of its strategy to position the company for long-term commercial success, including the anticipated closing of the Strongbridge Biopharma plc acquisition and evolution to a more commercially driven company. Barry Deutsch, Chief Financial Officer, has decided to step down from the CFO role effective immediately. Mr. Deutsch will remain with the Company in a transition role through the close of the Strongbridge transaction, which is expected to be completed early in the fourth quarter of 2021. Steven Pieper, Vice President of Finance, Mr. Deutsch’s planned successor, has been promoted to CFO responsible for accounting, financial reporting, tax, treasury, financial planning and analysis, and information systems. Mr. Pieper will report to Paul R. Edick, Chairman and CEO.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced an exclusive agreement with Tetris Pharma Limited (“Tetris”) for the commercialization of Ogluo® in the European Economic Area, United Kingdom, and Switzerland (the “Territory”) for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that on July 1, 2021, the Compensation Committee of Xeris’ Board of Directors granted restricted stock units for an aggregate of 80,250 shares of its common stock to 37 new employee(s) under Xeris’ Inducement Equity Plan.

Xeris Pharmaceuticals, Inc. (“Xeris”) (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, and Strongbridge Biopharma plc (“Strongbridge”) (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that they have entered into a definitive agreement under which Xeris will acquire Strongbridge for stock and contingent value rights (“CVRs”). The agreement, including the maximum aggregate amount payable under the CVRs, values Strongbridge at approximately $267 million based on the closing price of Xeris common stock of $3.47 on May 21, 2021 and Strongbridge’s fully diluted share capital. The transaction, which has been unanimously approved by the boards of directors of both companies, with the exception of Jeffrey W. Sherman, M.D., a director in common to both companies, who abstained from the voting, is expected to close early in the fourth quarter of 2021, subject to the satisfaction of closing conditions. Upon close of the transaction, the businesses of Xeris and Strongbridge will be combined under a new entity to be called Xeris Biopharma Holdings, Inc. (“Xeris Biopharma Holdings”).

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, and Strongbridge Biopharma plc (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that they have entered into a definitive agreement under which Xeris will acquire Strongbridge for stock and contingent value rights (“CVRs”). The agreement, including the maximum aggregate amount payable under the CVRs, values Strongbridge at approximately $267 million based on the closing price of Xeris Shares of $3.47 on May 21, 2021 and Strongbridge's fully diluted share capital. The transaction, which has been unanimously approved by the boards of directors of both companies, with the exception of Jeffrey W. Sherman, M.D., a director in common to both companies, who abstained from the voting, is expected to close early in the fourth quarter of 2021, subject to the satisfaction of closing conditions. Upon close of the transaction, the businesses of Xeris and Strongbridge will be combined under a new entity to be called Xeris Biopharma Holdings, Inc. (“Xeris Biopharma Holdings”).

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced financial results for the first quarter 2021 and recent highlights.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that Paul R. Edick, Chairman and Chief Executive Officer of Xeris Pharmaceuticals, will participate in following upcoming virtual events:

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the Company will release its first quarter 2021 financial results before the open of the U.S. financial markets on Thursday, May 13, 2021. Management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the Company’s financial and operational results.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that it has entered into an amendment to its existing loan and security agreement with Oxford Finance LLC (Oxford) and Silicon Valley Bank (SVB). The amendment allows for extensions of interest-only payments for up to 12 months, subject to certain conditions, to January 2023. The extensions allow the Company to delay principal payments of up to $17.4 million, which would have been due during the periods between January 1, 2022 and December 1, 2022, to periods beginning January 1, 2023. The final maturity date of the debt facility is June 1, 2024.

Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo® (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.