Novavax's stock surges almost 300% in the past month
Novavax stock (NVAX) is on a tear — soaring nearly 300% in the past month to $19.56 per share — following several pieces of good news.
The Food and Drug Administration (FDA) today finally set a deadline to review the company's COVID-19 vaccine for full approval.
Until now, Novavax's COVID-19 vaccine has only been available through an emergency use authorization (EUA) — a pathway used by the FDA to quicken access to vaccines during the pandemic.
Novavax announced Thursday in an SEC filing that the FDA has set April 2025 as the deadline to take action to either fully approve or deny the company's vaccine for commercial use. If approved, Novavax would finally be able to market its only commercially available product during the fall vaccine season, alongside rivals Pfizer (PFE) and Moderna (MRNA).
The news sent Novavax's stock soaring to more than $23 per share on Thursday morning, but it is still a far cry from the pandemic highs of nearly $300 per share in 2021.
In addition to the FDA deadline, the company also received positive news from the regulator's advisory panel, which chose the JN.1 strain of the coronavirus — a strain that Novavax has tested in its lab and is therefore prepared to produce at scale — for the September booster campaign.
JN.1 is part of the Omicron family, the last major strain to circulate the globe during the pandemic. It has been on the rise in the past few months in the US, but a new strain, KP.2, is taking over, according to the Centers for Disease Control and Prevention (CDC).
KP.2 now accounts for 28.5% of known cases, compared to 8% of JN.1, CDC data shows.
Since the two strains are part of the same Omicron family, the Novavax vaccine is likely to provide adequate support.
Novavax is one of the six original companies chosen to receive Operation Warp Speed funding to facilitate vaccine development during the start of the pandemic. It developed a vaccine based on a more common platform than the newer mRNA vaccines from Moderna and Pfizer. For that reason, the science community was excited when it showed promising results in clinical trials.
But a series of manufacturing snafus, which in turn soured its relationship with the FDA, resulted in Novavax struggling to get its vaccine to the finish line. It missed out on the COVID-19 vaccine windfall that the mRNA vaccine makers, and to some degree Johnson & Johnson (JNJ) with its less efficacious vaccine, were able to enjoy.
Novavax is also benefiting from investments from Sanofi (SNY), as the French pharma giant looks to license Novavax's platform and has taken a minority stake in the biotech.
Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. Follow Anjalee on all social media platforms @AnjKhem.
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