About IRADIMED CORPORATION Iradimed anticipates total revenue for the fourth quarter of 2024 to be in the range of approximately $19.2 million to $19.4 million, representing year-over-year growth of between 10% and 11% and sequential quarter- over-quarter growth of between 5% and 6%. Full-year 2024 total revenue is expected to be in the range of approximately $73.1 million to $73.3 million, compared to $65.6 million in the prior year period, representing year-over-year growth of between 11% and 12%. These f ...

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 ...

About Calidi Biotherapeutics 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 ...

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]

Human Resource Strategy and Reorganization As part of our ongoing commitment to establish SIMPPLE as an industry leader and partner of choice, we began the year with a strategic business-wide review and reshuffle of its leadership team. The Company made several new executive appointments, while repositioning key existing management roles to maintain organizational continuity, and retention of critical competencies. Furthermore, the Company engaged global organizational consulting firm Korn Ferry to conduct ...

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 ...

Expanding Distribution Network Creates Synergies for Safety Shot Yerbaé's retail success is supported by a growing distribution network. Over 1,000 new brands enter the market each year seeking retail distribution and distributor alignments. Yerbaé's growth within these distributors marks significant strides in chain driven retail business like Smith's, but also positions the company strategically across multiple new regional account locations and independent retailers. Within this segment of business, dist ...

On Sept. 23, 2024, Kaival entered into a definitive business combination agreement with Delta and Pubco. This 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 ("Nasdaq"). 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 combin ...