Reports preliminary fourth quarter 2024 revenue in the range of approximately $19.2 million to $19.4 millionReports preliminary full-year 2024 revenue in the range of approximately $73.1 million to $73.3 millionIradimed is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15th, 2025, at 5:15 p.m. PT  WINTER SPRINGS, Fla., Jan. 10, 2025 (GLOBE NEWSWIRE) -- IRADIMED CORPORATION (the "Company" or "Iradimed") (NASDAQ:IRMD), a leader in developing innovative Magnetic Resonance ...

First Quarter Fiscal 2025 Revenue Includes a One-Time Upfront Payment of $3.0 Million in Collaboration Revenue from Zimmer Biomet and $3.2M in Product Revenue Management to Host Virtual Investor Webinar Today at 11:00 a.m. Eastern Time EDEN PRAIRIE, Minn., Jan. 10, 2025 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorder ...

FREDERICK, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® ("TOMI") (NASDAQ:TOMZ), a global company specializing in disinfection and decontamination solutions, today announced that the Company is supporting partners and clients preparing for emerging public health threats as concerns grow over Respiratory Syncytial Virus (RSV), Human Metapneumovirus (HMPV), and the highly pathogenic Avian Influenza (H5N1). TOMI is leveraging its SteraMist technology to provide innovative infection ...

BOSTON, Jan. 10, 2025 /PRNewswire/ -- The Berkshire Hills Bancorp, Inc. (NYSE: BHLB) fourth quarter 2024 earnings release and conference call are scheduled as follows: Earnings Release:      Thursday, January 30, 2025, at approximately 7:30 a.m. (Eastern) Conference Call:        Thursday, January 30, 2025, at 9:00 a.m. (Eastern) Webcast (listen-only):  Register at: https://events.q4inc.com/attendee/539841607 Dial-in Number:          Toll Free: (800) 715-9871; Conference ID 6567963 Webcast Replay:         ht ...

SAN DIEGO, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE:CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced that it priced its public offering of 5,000,000 shares of common stock at a price of $0.85 per share.   The closing of the offering is expected to occur on or about January 10, 2025, subject to satisfaction of customary closing conditions. Ladenburg Thalmann & Co. Inc. is acting as ex ...

Partnership Agreement - Samsung Bioepis and Teva Pharmaceutical Industries have entered into a license, development, and commercialization agreement for EPYSQLI®, a biosimilar to Soliris®, in the US [1] - Samsung Bioepis will handle development, regulatory registration, manufacturing, and supply, while Teva will manage commercialization in the US [2] - EPYSQLI is indicated for treating rare diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) [3] Strategic Importance - The partnership aims to increase access to treatment for rare disease patients, addressing high costs and limited availability [4] - The collaboration aligns with Teva's Pivot to Growth strategy, expanding its biosimilar portfolio to 18 assets [5] - Samsung Bioepis' biosimilars portfolio now includes nine biosimilars available in over 40 countries, covering therapeutic areas such as immunology, oncology, and hematology [5] Regulatory Approvals - EPYSQLI was approved by the US FDA in July 2024 for PNH and aHUS, with an expanded indication for gMG in November 2024 [4] - The product received approval from the European Commission in May 2023 and Korea's Ministry of Food and Drug Safety in January 2024 [4] - EPYSQLI has been commercially available in Europe since July 2023 and in Korea since April 2024 [4] Product Details - EPYSQLI is a complement inhibitor used to treat PNH, aHUS, and gMG in adult patients who are anti-acetylcholine receptor (AchR) antibody positive [3][6] - The product is not indicated for Shiga toxin E coli-related hemolytic uremic syndrome (STEC-HUS) [8] - EPYSQLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of serious meningococcal infections [10][17] Safety Information - EPYSQLI increases the risk of serious infections caused by Neisseria meningitidis, which can be life-threatening or fatal [9][12] - Patients must complete or update meningococcal vaccination at least two weeks prior to the first dose of EPYSQLI [13][15] - Monitoring for early signs of meningococcal infection is critical, and treatment should be interrupted if serious infection occurs [16] Adverse Reactions - Common adverse reactions in PNH trials include headache, nasopharyngitis, back pain, and nausea [27] - In aHUS trials, frequent adverse reactions include headache, diarrhea, hypertension, and upper respiratory infection [27] - In gMG trials, musculoskeletal pain was the most frequently reported adverse reaction [28]

Singapore, Jan. 10, 2025 (GLOBE NEWSWIRE) -- SIMPPLE Ltd. (NASDAQ:SPPL) ("SIMPPLE" or "the Company"), a leading technology provider and innovator in the facilities management (FM) sector, today announced that Norman Schroeder, the Company's Chief Executive Officer, has issued the following Letter to Shareholders. Dear Shareholders: As we reflect and assess the year that has been, I would like to thank you for your continued confidence, and support throughout 2024, a transformative year of growth, delivering ...

Nashville, TN, Jan. 10, 2025 (GLOBE NEWSWIRE) -- American Rebel Holdings, Inc. (NASDAQ:AREB) ("American Rebel" or the "Company"), a designer, manufacturer, and marketer of branded safes, personal security, self-defense products, apparel, and American Rebel Beer (www.americanrebelbeer.com), is proud to announce the delivery of the initial shipment of American Rebel Light Beer to its recently established distribution partner, Clark Distributing Company (www.ccclark.com), for the Commonwealth of Kentucky annou ...

SCOTTSDALE, Ariz., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Yerbaé Brands Corp. (TSXV:YERB, OTCQX:YERBF) ("Yerbaé" or the "Company"), a plant-based functional beverage company, announced today new partnerships with Carlson Distributing, Bison Beverage, George's Distributing, and Craig Stein Beverage to service Smith's Food & Drug locations across the western United States. Smith's Food & Drug, a regional grocery chain with locations in Utah, Nevada, New Mexico, Arizona, Montana, Idaho, and Wyoming, is a subsidiary ...

Transaction Overview - Kaival Brands Innovations Group Inc and Delta Corp Holdings Limited have jointly announced the public filing of a registration statement on Form F-4 with the SEC by Delta Corp Holdings Limited, a newly created holding company organized under the laws of the Cayman Islands [2] - The proposed transaction will result in Kaival and Delta becoming wholly-owned subsidiaries of Pubco, which will be a new public company whose ordinary shares trade on the Nasdaq Capital Market [8] - The business combination is valued at $301 million and is expected to close in February 2025, subject to the registration statement being declared effective by the SEC, the approval of both companies' shareholders, certain regulatory approvals, as well as the satisfaction or waiver of other closing conditions [11] Company Information Kaival Brands Innovations Group Inc - Kaival Brands is a company focused on incubating and commercializing innovative products into mature and dominant brands, with a current focus on the distribution of electronic nicotine delivery systems (ENDS) also known as "e-cigarettes" for use by customers 21 years and older [9] - The company plans to diversify into distributing other nicotine and non-nicotine delivery system products, including those related to hemp-derived cannabidiol (CBD) products [9] - Kaival Brands and Philip Morris Products S A are the exclusive global distributors of all products manufactured by Bidi Vapor LLC [9] Delta Corp Holdings Limited - Delta Corp Holdings Limited is a fully integrated global enterprise engaged in logistics, fuel supply, and asset management services, primarily supporting the international supply chains of commodity, energy, and capital goods producers [12] - The company operates through three main segments: Bulk Logistics, Energy Logistics, and Asset Management [12] - Delta maintains executive offices in Dubai and New York, and has a significant commercial presence in Singapore, Rotterdam, New Delhi, and Mumbai [12] Transaction Details - The registration statement on Form F-4 includes a preliminary prospectus with respect to the securities to be issued to holders of securities of Kaival and Delta in connection with the proposed business combination, and a preliminary proxy statement relating to the special shareholders meeting of Kaival at which shareholders of Kaival will vote on whether to approve the transactions [11] - Investors and security holders are urged to read the proxy statement/prospectus and the other relevant materials before making any voting or investment decision with respect to the proposed merger [3][5] - A copy of the registration statement is available for review on the SEC's website [4]