Shares of the next-generation vaccine developer Novavax (NVAX -1.17%) jumped by as much as 15% in premarket trading Monday morning. The company's stock is up by double-digits in early morning action today in response to three positive regulatory updates for its protein-based COVID-19 vaccine candidate known as NVX-CoV2373.
Specifically, ahead of the opening bell, the biotech announced that it has now completed the vaccine's regulatory application in Canada and submitted all of the necessary regulatory paperwork for the vaccine's approval in the European Union. Novavax noted in its press release that the final step to completing the application in the European Union will be an invitation from the European Medicines Agency to file for Conditional Marketing Authorization. Additionally, the biotech also announced that Indonesia has granted the vaccine emergency use authorization in the country, marking the vaccine's first official regulatory approval.
Novavax's shares have essentially been in free fall over the last few weeks. Investors have been backing away from this COVID-19 vaccine stock of late due to a combination of missed regulatory deadlines and concerns about the manufacturing process for its vaccine. In fact, Novavax's shares were down by a whopping 53% from their 52-week highs prior to this morning's sizable rally. The long and short of it is that Novavax is slowly but surely proving its critics wrong with this series of regulatory filings for NVX-CoV2373.
Is Novavax's stock a buy on this news? I think the answer is a resounding yes. The biotech's shares were unfairly punished for an article in Politico that relied on anonymous sources to question the capabilities of its manufacturing partners. While Novavax has indeed missed its self-imposed regulatory deadlines for the all-important U.S. market this year, these global regulatory filings are proof positive that the company can manufacture this vaccine at scale. Novavax's stock, in turn, should continue to rebound for the remainder of the year.