Welcome to our dedicated page for VBI Vaccines New news (Ticker: VBIV), a resource for investors and traders seeking the latest updates and insights on VBI Vaccines New stock.
VBI Vaccines Inc. (NASDAQ: VBIV) is a leading biopharmaceutical company focused on developing next-generation vaccines to meet unmet needs in infectious diseases and immuno-oncology. Headquartered in Cambridge, MA, with research facilities in Ottawa, Canada, VBI is at the forefront of vaccine innovation with two primary platforms.
The first platform, Enveloped Virus-Like Particle (eVLP), enables the design of vaccines that closely mimic the target virus, enhancing their effectiveness. The company's lead eVLP asset is a prophylactic cytomegalovirus (CMV) vaccine, currently advancing with GMP manufacturing for formal preclinical and Phase I trials.
The second platform is a thermostable technology allowing vaccines and biologics to withstand fluctuating temperatures during storage and transport. VBI has completed proof-of-concept thermostability studies on several vaccine and biologic targets, highlighting this platform's potential to improve global vaccine distribution.
VBI's commercial product, Sci-B-Vac, is a hepatitis B (HBV) vaccine approved for adults, children, and newborns. The company's innovations are designed to address significant gaps in the vaccine market, particularly in underserved areas.
Recent achievements include the initiation of GMP manufacturing for its CMV vaccine candidate and successful proof-of-concept studies for its thermostable technology. VBI continues to be a pivotal player in the biopharmaceutical field, dedicated to advancing public health through cutting-edge vaccine solutions.
VBI Vaccines Inc. (Nasdaq: VBIV) reported its Q1 2022 financials, highlighting the commercial launch of its 3-antigen adult HBV vaccine, PreHevbrio, in the U.S. and its European approval as PreHevbri. The company ended Q1 with $101.3 million in cash, but reported a revenue decline to $0.1 million from $0.3 million year-over-year. R&D expenses significantly decreased to $2.4 million. VBI anticipates Phase 2 clinical data for its HBV immunotherapeutic candidate, VBI-2601, by year-end 2022 and plans multiple new clinical studies in the next six months.
VBI Vaccines Inc. announced that the European Commission granted Marketing Authorization for PreHevbri™, the only approved 3-antigen hepatitis B vaccine for adults in the EU and EEA. This authorization follows a positive opinion from the European Medicines Agency’s CHMP in February 2022. PreHevbri™ aims to enhance immunization against hepatitis B and potentially prevent hepatitis D. VBI plans to make the vaccine available in selected European countries by the end of 2022, after receiving FDA approval in the U.S. in late November 2021.
VBI Vaccines (NASDAQ: VBIV) announced that data from its Phase 2a study of cancer vaccine candidate VBI-1901, targeting recurrent glioblastoma (GBM), will be presented at the 2022 ASCO Annual Meeting. The data was selected for a poster session and a poster discussion session, highlighting its relevance to clinical practice and future research. This study aims to assess tumor response and overall survival in GBM patients. Annually, approximately 12,000 new GBM cases are diagnosed in the U.S., indicating the critical nature of this research.
VBI Vaccines Inc. (NASDAQ: VBIV) announced promising Phase 1b clinical data for its vaccine candidate VBI-2905, demonstrating a well-tolerated safety profile and a significant boost in immune response against the Beta variant of SARS-CoV-2. Additionally, preclinical data for VBI-2901 indicates superior antibody responses across various coronavirus variants. The company aims to initiate the first clinical study of VBI-2901 in summer 2022. VBI's vaccine program benefits from substantial funding, including a partnership with CEPI and contributions from the Canadian government.
VBI Vaccines Inc. has announced the availability of PreHevbrio™, the only approved 3-antigen hepatitis B vaccine for adults in the U.S. Approved by the FDA in November 2021, PreHevbrio aims to combat all known subtypes of hepatitis B virus (HBV) in adults aged 18 and older. The vaccine is priced at $64.75 per dose and has been included in the ACIP's list of recommended adult HBV vaccines since February 2022. VBI is establishing a distribution network to ensure broad access to this vaccine.
VBI Vaccines Inc. (Nasdaq: VBIV) announced that President and CEO Jeff Baxter will participate in a fireside chat at the 32nd Annual Oppenheimer Healthcare Conference on March 16, 2022, from 10:00-10:30 AM ET. The event will be accessible via a live webcast, which will be archived on the Company's website afterward. VBI focuses on immunology-driven biopharmaceutical solutions, developing vaccines that target infectious diseases like hepatitis B and aggressive cancers through innovative virus-like particle technology.
VBI Vaccines (Nasdaq: VBIV) announced its financial results for 2021, reporting a net loss of $69.8 million ($0.27 per share), compared to a loss of $46.2 million in 2020. The company ended the year with $121.7 million in cash. Key achievements included FDA approval of the PreHevbrio HBV vaccine, added to the ACIP recommended list in February 2022. Two Phase 2 studies for the therapeutic HBV candidate commenced, and Fast Track Designation was granted for VBI-1901 targeting glioblastoma. Revenue dropped to $0.6 million from $1.1 million in 2020 due to decreased R&D services.
QualTek Services Inc. (NASDAQ: QTEK) announced the appointment of Daniel Lafond as an independent board member, effective March 2, 2022. Lafond brings over 20 years of experience from companies like AT&T and Comcast. This appointment follows the earlier additions of Jigisha Desai and Sam Chawla to the board. QualTek aims to enhance leadership during a significant growth period, focusing on the execution of its 5G network backlog. The company operates across North America with a workforce of over 5,000, targeting telecommunications and renewable energy sectors.
VBI Vaccines Inc. announced a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for their 3-antigen hepatitis B vaccine, named PreHevbri™. This vaccine is recommended for active immunization against hepatitis B in adults, with a final decision from the European Commission expected soon. If approved, PreHevbri will be the only 3-antigen hepatitis B vaccine available for adults in the EU. Positive data from pivotal Phase 3 clinical trials support this recommendation, emphasizing the vaccine's potential in tackling hepatitis B, a significant global health issue.
VBI Vaccines Inc. has announced that its hepatitis B vaccine, PreHevbrio™, is now included in the CDC’s Advisory Committee on Immunization Practices (ACIP) recommendations for adult vaccination against HBV. Following FDA approval on
PreHevbrio is expected to be commercially available in the U.S. by the end of Q1 2022. This vaccine targets all known subtypes of HBV and aims to significantly contribute to national public health goals by 2030.
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