Novavax (NVAX) shares surged 7.52% in pre-market trading on Wednesday following positive developments in the company's interactions with the U.S. Food and Drug Administration (FDA) regarding its COVID-19 vaccine. The biotechnology company's stock price movement comes amidst renewed optimism about the potential approval of its Biologics License Application (BLA).

According to a recent SEC filing, Novavax announced that the FDA has requested a post-marketing commitment (PMC) for additional clinical data for its COVID-19 vaccine. Despite this request, the company remains confident in the approvability of its BLA. In a statement, Novavax affirmed, "We believe that our BLA is approvable based on conversations with FDA, as of our PDUFA date on April 1 and through today."

The company has expressed its intention to engage with the FDA to address the PMC request, signaling a cooperative approach towards meeting regulatory requirements. This proactive stance and the ongoing dialogue with the FDA appear to have boosted investor confidence, contributing to the significant pre-market rally. As Novavax continues to navigate the regulatory landscape, market participants will likely keep a close eye on further developments in the company's pursuit of full approval for its COVID-19 vaccine.