Novavax (NVAX) stock soared 7.52% in pre-market trading following encouraging news about the company's interactions with the U.S. Food and Drug Administration (FDA) regarding its COVID-19 vaccine. The surge comes as investors react positively to the latest developments in the vaccine's approval process.

According to a recent SEC filing, the FDA has requested a post-marketing commitment (PMC) for additional clinical data on Novavax's COVID-19 vaccine. In response, Novavax has stated its intention to engage with the FDA to address this request. This move is seen as a step forward in the regulatory process, as it suggests that the FDA is considering approval with additional post-market studies rather than outright rejection.

Adding to the optimism, Novavax expressed confidence in its Biologics License Application (BLA), stating, "We believe that our BLA is approvable based on conversations with FDA, as of our PDUFA date on April 1 and through today." This statement indicates that the company has had positive discussions with the FDA and remains optimistic about the eventual approval of its vaccine. The combination of these factors has likely fueled investor enthusiasm, leading to the significant pre-market price increase.