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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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August 13, 2014
10:01 EDTNVAXOn The Fly: Analyst Initiation Summary
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06:14 EDTNVAXNovavax initiated with a Buy at Citigroup
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