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January 24, 2013
08:31 EDTNVAXNovavax says BARDA continues contract for both seasonal, pandemic flu programs
Novavax announced that the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority, or BARDA, has completed an In-Process Review of Novavax' contract covering the company's recombinant virus-like particle vaccine candidates for pandemic and seasonal influenza. The contractually-defined IPR was conducted by a team of U.S. Government experts, who provided input on Novavax' progress during the contract base period and plans for further development, including both near-term process development and manufacturing activities and longer-term clinical efforts. BARDA has notified the company that based on the results of the IPR, a milestone decision has been made to continue the contract for both the seasonal and pandemic influenza programs. In March 2011, Novavax was awarded a contract valued at up to $179M by BARDA for the advanced development of recombinant vaccines for the prevention of seasonal and pandemic influenza. In the midst of the contract's 3-year base period, valued at $97M, Novavax has been developing and testing its novel recombinant virus-like particle influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. The contract can be extended for an additional 24-month option period at BARDA's option, with $82M in additional funding to build on the work Novavax accomplishes during the base period and to support manufacturing scale-up and licensure by the U.S. Food & Drug Administration.
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July 30, 2015
08:39 EDTNVAXNovavax reports positive data from Phase 2 trial of Quadrivalent
Novavax announced positive top-line data from a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle, or VLP, vaccine candidate. This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Department of Health and Human Services under the Company’s contract with HHS-BARDA. The trial demonstrated that the Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events. The trial met its immunogenicity targets and demonstrated potential to meet the Center for Biological Evaluation and Research criteria for accelerated approval. Novavax’ technology platform enables the creation of recombinant, strain-specific VLPs. Novavax’ Seasonal Influenza VLP consists of VLPs representing four different strains of influenza virus, each expressing strain-specific hemagglutinin and neuraminidase antigens. This dose-ranging clinical trial was designed to evaluate the safety and immunogenicity of the Seasonal Influenza VLP in 400 healthy adults. The primary outcomes of the trial assessed safety and tolerability of the Seasonal Influenza VLP and quantified immune responses to each of the four influenza strains based on hemagglutination-inhibiting antibody titers. The secondary outcomes evaluated neuraminidase-inhibiting antibody titers for all four influenza strains.
July 21, 2015
11:00 EDTNVAXNovavax price target raised to $15 from $10.50 at Piper Jaffray
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09:21 EDTNVAXOn The Fly: Pre-market Movers
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08:34 EDTNVAXNovavax announces positive top-line data from Phase 1 ebola vaccine trial
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