An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma. CAMBRIDGE, Mass.--(BUSINESS WIRE)-- VBI Vaccines Inc. (VBIV) , a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration … The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno … Press Release reported on 02/02/21 that VBI Vaccines Announces U.S. FDA Acceptance of BLA Filing for VBI’s 3-Antigen Prophylactic Hepatitis B Vaccine Get the hottest stocks to trade every … We are committed to working with the FDA throughout their review process over the course of this year as we work to address this serious, but preventable, public health threat.”. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel. We and our partners will store and/or access information on your device through the use of cookies and similar technologies, to display personalised ads and content, for ad and content measurement, audience insights and product development. VBI Vaccines Announces U.S. FDA Acceptance of BLA Filing for VBI's 3-Antigen Prophylactic Hepatitis B Vaccine. Investors: http://www.vbivaccines.com/investors/, Cautionary Statement on Forward-looking Information. VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBIV stock is a high-risk/high-return investment. You can change your choices at any time by visiting Your Privacy Controls. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. But, if Sci-B-Vac is not approved, the stock could fall significantly. VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. If all goes to plan, VBIV expects to find a commercial … Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. This site is protected by reCAPTCHA and the Google Website Home: http://www.vbivaccines.com/ This vaccine is sold under the name Sci-B-Vac® in Israel. Shares of VBI Vaccines (NASDAQ:VBIV) jumped 11.3% on Wednesday after the company reported its first-quarter financial results and updated investors on its clinical-stage drug pipeline. VBI Vaccines (VBI) is a commercial-stage biopharmaceutical company focused on the development and commercialization of vaccines and therapeutics targeting immuno-oncology and … The first one, VBI-2901, is a trivalent pan-coronavirus vaccine candidate expressing the SARS-CoV-2 (COVID-19), SARS-CoV (SARS) and MERS-CoV (MERS) spike proteins while the second … Yet, with analysts’ average price target on the shares standingt at $4.50, VBIV may be worth the risk. Bad news about rising COVID-19 cases ... VBI Vaccines (NASDAQ:VBIV) and Dynavax ... Co-Diagnostics sells COVID-19 diagnostics tests that have received emergency use authorization from … The latest news and events at the U.S. Food and Drug Administration (FDA) and resources for journalists. Nicole Anderson Terms of Service apply. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; unanticipated delays in both the commencement and completion of our planned clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products.
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