Novavax (NVAX +1.04%) shares gained more than 2,600% last year as the clinical-stage biotech became one of the front-runners in the race to develop a coronavirus vaccine -- and was awarded $1.6 billion from the U.S. government to support its efforts.
That was a genuinely amazing performance, and as 2021 begins, Novavax still has a lot on its agenda. Here are three things investors should be looking for from the company this year.
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1. A possible coronavirus vaccine -- and revenue
Novavax has a late-stage clinical trial for its coronavirus vaccine candidate, NVX-CoV2373, well underway in the U.K., and could be ready to report interim data from it early in the current quarter. If that data is positive, the company will use it to support its submissions to various major healthcare regulators.
Regulatory agencies granted emergency use authorizations for the COVID-19 vaccines of Pfizer (PFE 0.74%) and Moderna (MRNA 0.20%) within weeks of their phase 3 interim reports. If Novavax's fortunes are similar, the company could begin generating vaccine revenue in the first half of 2021. NVX-CoV2373 would be its first marketed product -- a huge step for the company.
2. A NanoFlu regulatory submission
Last spring, Novavax reported that its flu vaccine candidate met all primary endpoints in a pivotal trial. Later in the year, the company assembled a team of experts to shepherd NanoFlu through the regulatory approval process.
Novavax hasn't said when it will submit its application for NanoFlu to the Food and Drug Administration. But it did say it would apply to have that vaccine reviewed under the FDA's accelerated approval pathway. It's possible a submission could happen at some point this year.
3. Progress on a combined coronavirus/flu vaccine
In October, Novavax said it would begin exploring the possibility of producing a single shot that combines both its coronavirus and flu vaccines. The company said any such dual-purpose product would be for post-pandemic use. Novavax didn't provide other timeline details. But we could imagine that it may report preclinical data or other early details on this project this year.
Positive results on any of the fronts listed above could provide a catalyst for Novavax's shares. So even though its 2020 stock price gain was massive, there's room for additional good news to drive this biotech company even higher.
