Novavax NVAX Stock News

Novavax, Inc. (NASDAQ: NVAX) is rocketing in the market this morning, trading on gains of about 40% early on. The gains come after the company announced positive data from a Phase 3 clinical trial. Here’s what’s happening:

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NVAX Stock Jumps On Positive Phase 3 Results

In a press release issued early this morning, Novavax provided top-line results from a Phase 3 clinical trial of NanoFlu. NanoFlu is a recombinant quadrivalent seasonal influenza vaccine candidate. The candidate was developed with the company’s proprietary Matrix-M adjuvant, and has proven to be effective in an elderly patient population.

In the release, NVAX said that using FDA criteria for acclerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu. In particular, NanoFlu was put head to head against Fluzone, a U.S.-licensed quadrivalent influenza vaccine.

During the trial, the company worked to demonstrate non-inferiority in the immunogenicity of NanoFlu when compared to Fluzone. The trial also aimed at showing a difference between seroconversion rates in the two vaccine options. Finally, the company also worked to establish a favorable safety profile.

Importantly, all primary endpoints were achieved. Moreover, the vaccine proved to be safe and well tolerated with a modest increase in local adverse events.

In the release, NVAX said that the secondary endpoints were all met as well. In fact, the vaccine led to higher GMT responses and higher SCR percentages. In a statement, Stanley C. Erck, President and CEO at NVAX, had the following to offer:

With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine. These strong Phase 3 results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.

The above statement was followed up by Gregory Glenn, M.D., President of Research and Development at Novavax. Here’s what he had to say:

In addition to meeting the primary objectives, we are very pleased to report that NanoFlu also met or exceeded its secondary endpoints for all four strains using our proprietary HAI assay based upon wild-type reagents. NanoFlu demonstrated significant improvement against four drifted H3N2 strains that are co-circulating this year. These data, similar to what was shown in our Phase 2 clinical trial, demonstrate that NanoFlu overcomes issues related to egg-adaptation and antigenic drift. We extend our sincere appreciation to those who volunteered for this important study and to our clinical partners who worked so quickly and diligently on this trial.

Why This News Is So Important

While the world is heavily focused on the coronavirus, it’s important that we don’t discount the importance of a continued fight against the flue. Keep in mind, the flu kills more than 50,000 people every year.

Current flu vaccines are losing efficacy. NVAX aims to change that with NanoFlu, and the company seems to be doing a great job. With this solid Phase 3 data, in my view, it’s only a matter of time before the vaccine makes it through the FDA approval process and to the market.

It’s also important to keep in mind that the success here outlines the benefits of the company’s Matrix-M technology. This is the same technology that the company is taking advantage of in an attempt to create a vaccine that works against COVID-19.

So, the strong results here not only mean that NVAX is making its way to market soon, they also likely mean that the comapny’s coronavirus vaccine will be just as promising. All in all, this is a stock that should not be ignored.

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