NVAX stock in notable setup ahead of FDA meeting on COVID-19 shot (NASDAQ:NVAX)

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Amid concerns over the U.S. regulatory nod and the initial rollout of the company’s COVID-19 shot, Novavax (NASDAQ:NVAX) shares have plummeted this year against a backdrop of a key FDA meeting on the use of the vaccine in the home market next month.

The federal agency announced last Friday that a group of its vaccine experts would meet on June 07 to discuss the company’s request for the authorization of the protein-based vaccine for use in those aged 18 years older.

A favorable opinion will mark the addition of a differentiated tool to the COVID-19 immunization drive at a time more than 10% of U.S. adults remain unvaccinated more than a year after two mRNA-based vaccines and a vector-based vaccine were introduced to the COVID weary public.

For Maryland-based Novavax (NVAX), it will be a validation of its Matrix-M adjuvanted vaccine platform, the candidates of which include a combined seasonal influenza vaccine that joins the COVID-19 shot with a quadrivalent flu vaccine.

While the company shares ended a three-day skid last Friday after the announcement of the FDA review, Novavax (NVAX) stock continues to trade ~68% lower than the level at the start of the year.

Interestingly, Moderna (MRNA) and BioNTech (BNTX), which – similar to Novavax (NVAX) – boast their COVID-19 shots as the only products in their portfolio, have fallen only ~46% YTD, as shown in this graph.

The underperformance is striking as more than a dozen countries, including the EU and the World Health Organization (WHO) have already greenlighted the Novavax (NVAX) vaccine for adults.

More positive regulatory news could be along the way. Last month, the company requested the EU regulators to expand the marketing authorization for its vaccine, branded as Nuvaxovid in the region, to include adolescents.

However, the slow rollout of the vaccine remains a concern as supply constraints for vaccines ease and COVID-19 worries in many countries abate. None of the analysts covering the stock have raised the quarterly earnings estimates for Novavax (NVAX) over the past three months.

Meanwhile, the consensus suggests ~$4.5 billion revenue for the company in 2022, about 64% higher than the projections made by data analytics firm Airfinity for Novavax (NVAX) vaccine for this year. Yet, the company remains a favorite on Wall Street with no Sell ratings, currently.

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