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May 12, 2014
09:28 EDTNVAXNovavax says data support accelerating plans for 'seasonal' elderly RSV vaccine
Novavax announced follow-up data from its dose-ranging Phase 1 clinical trial of its respiratory syncytial virus F-protein vaccine in 220 elderly adults that was initiated in October 2012. In the placebo-controlled trial, subjects received a single injection of either 60g or 90g of the RSV F-protein vaccine candidate, with or without aluminum phosphate as an adjuvant. In the one-year follow up data released by Novavax, the company reported that the group receiving the 90g dose without adjuvant, anti-F levels and PCA were significantly elevated over baseline at day 118, with a geometric mean of 130g/ml, and at day 180, with a geometric mean of 114g/ml. The company said, "We were pleased to see that a 90g dose of our RSV F vaccine candidate was immunogenic and sustained levels that appear to be protective over an entire RSV season. These results encourage us to accelerate our development plans to include an annual seasonal RSV vaccine for the elderly where there is a burden of disease and incidence rate similar to that of an influenza virus, and clearly support initiation of a Phase 2 clinical trial as early as later this year or early-2015."
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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 Companys 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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