Novavax’s stock (NASDAQ:NVAX) has experienced a remarkable surge, skyrocketing by nearly 300% in the past month to $19.56 per share, propelled by a series of positive developments.
The Food and Drug Administration (FDA) recently announced a deadline for reviewing Novavax’s COVID-19 vaccine for full approval. Previously only available under emergency use authorization (EUA), the vaccine is now slated for a decision by April 2025. This potential approval would allow Novavax to enter the fall vaccine season alongside competitors Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA).
The announcement propelled Novavax’s stock to over $23 per share on Thursday morning, although still a considerable distance from its pandemic peak of nearly $300 per share in 2021.
In addition to the FDA deadline, Novavax received encouraging news from the regulator’s advisory panel. The panel selected the JN.1 strain of the coronavirus, a strain Novavax has extensively tested and is prepared to produce at scale, for the September booster campaign. Despite the rise of the KP.2 strain, which now accounts for 28.5% of known cases compared to JN.1’s 8%, both strains belong to the Omicron family, indicating the potential efficacy of the Novavax vaccine against both variants.
Novavax, one of the original Operation Warp Speed recipients, utilized a common platform for its vaccine, distinguishing it from the mRNA vaccines of Moderna and Pfizer. Despite initial promise in clinical trials, manufacturing challenges strained Novavax’s relationship with the FDA, hindering vaccine distribution. Unlike mRNA vaccine makers and Johnson & Johnson (NYSE:JNJ), Novavax missed out on the COVID-19 vaccine profitability.
Furthermore, Novavax benefits from investments by Sanofi (SNY), which seeks to license Novavax’s platform and has acquired a minority stake in the biotech company.
Featured Image: Megapixl
Author Faith Yakubu 
