It was not long that the world was witnessing Covid-19’s retreat and readying itself for a return to normalcy. That has proved to be presumptuous with the mutant strains and Delta variant, in particular, indicating the coronavirus remains with us for the time being. Which in a macabre sort of way might be good news for the perpetually late Novavax (NVAX).
The vaccine maker had already delayed the submission of its EUA (emergency use authorization) filing for its vaccine candidate NVX-Cov2373 from May to Q3, but has now pushed back the application’s submission to the FDA to Q4, as the company has been told to “prioritize alignment” with the FDA on its analytic methods.
As would be expected, the market did not like the latest development and sent shares tumbling by 20% in the subsequent session.
Long time Novavax bull, B. Riley’s Mayank Mamtani is non-plussed, and in time-honored Wall Street fashion, implores investors to follow an old piece of advice.
“We would be additional buyers on weakness since we and Street weren't anyway modeling U.S. sales until 1H22, as per prior mgmt. guidance; and remain encouraged that EUA path remains still viable despite PFE's C-19 vaccine anticipated to secure full BLA approval within 3Q,” the 5-star analyst said.
In the meantime, the regulatory package for emergency use authorization has been submitted in various countries including India, Indonesia, and Philippines. Novavax also remains on track to file for Emergency Use Listing with the World Health Organization, while submission with the U.K.'s MHRA should go ahead in the "coming weeks.” This should lay the groundwork for further filings with the European Medicines Agency (EMA) and regulatory bodies in Australia, Canada and New Zealand. Mamtani believes the “strength of '2373 clinical data and rigor applied to non-clinical CMC are likely to translate in several EUAs granted within 3Q.”
With strong global demand for the vaccine and seeming resolution to “manufacturing bottlenecks,” meaning NVAX could supply over 500 million doses by YE21 – “incrementally higher than prior projections,” – Mamtani believes a price target hike for the stock is in order. The figure rises from $286 to $305, indicating upside potential of ~44% from current levels. Needless to say, Mamtani’s rating stays a Buy. (To watch Mamtani’s track record, click here)
Looking at the consensus breakdown, 3 other analysts agree with Mamtani’s positive thesis while 2 others remain on the fence with a Hold, all culminating in a Moderate Buy consensus rating. The average price target stands at $253.40, suggesting returns of ~19% on the one-year time frame. (See Novavax stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.