In a post-market announcement last night, Novavax (NASDAQ:NVAX) said they have delayed trials of their influenza vaccine until 2013 after the FDA denied fast-track status to their lead candidate. Preliminary results from the current mid-stage trial showed that the vaccine met its primary goal of triggering an immune response to four viral strains. The therapy failed, however, to meet a secondary goal that would have potentially allowed accelerated approval through the FDA. Patients achieved antibody production for three of the influenza strains, but not the fourth, according to FDA requirements. Although the study was “on balance,” the company said it will wait until the next year to begin another Phase II study. Shares are up 10% today on the positive trial results and may continue to rise back towards the 52-week high of $2.17, but don’t expect a breakout soon.
The company announced in July that they will be partnering with the International Centre for Genetic Engineering and Biotechnology in India to develop a new malaria vaccine. The Indian government will fund the project, also partnered with CPL Biologics for production capabilities.