Shares of Novavax (NVAX) tumbled 5.44% in pre-market trading on Wednesday as the company faces a setback in its regulatory process. The biotechnology firm announced it needs to engage with the U.S. Food and Drug Administration (FDA) to address a post-marketing commitment (PMC) request, according to a recent SEC filing.

Despite the negative market reaction, Novavax remains optimistic about its Biologics License Application (BLA). The company stated, "We believe that our BLA is approvable based on conversations with FDA, as of our PDUFA date on April 1 and through today." This suggests that while there are additional requirements to be met, Novavax is confident in the overall approvability of its application.

The pre-market plunge reflects investor concerns about potential delays or complications in the regulatory process. As Novavax works to address the FDA's request, market participants will be closely monitoring further developments and their potential impact on the company's product approval timeline and overall business outlook.