Novavax, Inc. (NASDAQ: NVAX) is having an incredibly strong start to the trading session this morning, and for good reason. The company released clinical data from its flu vaccine trial. Of course, the data was positive, sending the stock on a run for the top. Today, we’ll talk about:
- The data that was released;
- what we’re seeing from the stock; and
- what we’ll be watching for ahead.
NVAX Releases Clinical Data
As mentioned above, Novavax is having a great day in the market today after announcing results from a Phase 2 clinical trial. In a press release issued after-hours yesterday, the company announced top-line results from its clinical trial of NanoFlu.
During the trial, the company compared the safety and immune response of various quadrivalent formulations of NanoFlu with or without its Matrix-M adjuvant with two U.S.-licensed influena vaccines. The treatment was given to 1,375 healthy adults aged 65 and older.
In the release, NVAX said that all formulations of NanoFlu were well-tolerated and elicited vigorous immune responses to the four strains included in the vaccine. The company’s Matrix-M adjuvant resulted in significant enhancement of immune responses when compared to the unadjuvanted formulation. Also, the company said that the formulation for the Phase 3 trial has been identified.
It’s also worth mentioning that the FDA has acknowledged that the accelerated approval pathway may be available for the treatment. As a result, the company intends on having a meeting with the FDA in the first half of 2019 to discuss the data, the proposed Phase 3 design and the use of accelerated approval for licensing.
In a statement, Gregory Glenn, M.D., President of R&D at NVAX, had the following to offer:
The superior immunogenicity against wild-type H3N2 viruses holds promise that NanoFlu will more effectively address the mismatch between circulating viruses and the strains included in most commercial vaccines due to genetic drift and vaccine virus egg adaptation. Older adults experienced the brunt of the serious health consequences of this mismatch, with H3N2 driving the majority of influenza hospitalizations and death during 2017-2018, the worst flu season in four decades. Over the past several years, influenza vaccine effectiveness has been suboptimal in this population, and there is broad agreement that better vaccines are needed. These confirmatory data from the second clinical trial of NanoFlu further justify continued rapid development of an improved vaccine.
The above statement was followed up by Stanley C. Erck, President and CEO at NVAX. Here’s what he had to offer:
The Phase 2 clinical trial results with NanoFlu demonstrate the potential impact our vaccine can make in preventing serious disease caused by influenza in older adults, a high-risk population that has proven difficult to protect in recent years. Our goal remains to advance to the market an improved vaccine that addresses the serious global public health threat that exists for older adults, and ultimately to make NanoFlu available to all populations.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves in the market. When it comes to Novavax, the news proved to be overwhelmingly positive. After all, the strong data means that the company will continue to move forward with development, this time, pushing into late-stage trials. So, it’s not surprising that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:23), NVAX is trading at $2.26 per share after a gain of $0.22 per share or 10.78% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on NVAX. In particular, we’re interested in following the story surrounding the development of NanoFlu as the treatment seems to be yielding positive results at the moment. We’re also following the company’s work with regard to the ResVax as data from this vaccine should be coming soon. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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