WWell, it finally happened. After a series of delays which resulted in a recent Politico article saying that Novavax (NVAX) was unable to obtain the manufacture of its Covid-19 vaccine (NVX-CoV2373) up to the standard required for filing with regulators, the company finally submitted its EUA dossier to the UK MHRA (Medicines and Healthcare products Regulatory Agency).
“It is important,” said Mayank Mamtani, analyst at B. Riley, “The dossier with the MHRA includes all the modules required for the regulatory review, including CMC data from the manufacturing partner, the Serum Institute of India. . ” This suggests that all of the manufacturing issues faced by the company have now been resolved.
While questions have been raised as to whether Novavax has missed the boat with Covid once again on the back, the UK has in fact seen a new wave of cases increase with the emergence of the ‘delta plus’ variant. . This suggests that the pandemic is still a constant concern across the pond. As such, Mamtani believes the NVX-CoV2373 “could serve as a 2nd hit in mix-and-match and a 3rd hit in heterologous boost settings.”
There are also expected to be other regulatory filings coming up, notably in the EU, Canada and Australia, for which Mamtani expects the application package to include the same set of data. An EUA application to the FDA is also expected to take place before the end of the year. The review process for other approved vaccines lasted between two weeks and a month, the analyst noted.
As the FDA cleared Moderna and JNJ’s COVID-19 booster injections with limited data, including the ability to mix and match boosters “in days,” Mamtani believes this “paradigm sets the bar low” for Novavax enters the market booster. In addition, the latest FDA statements suggest that the EUA’s door “remains open” for the Novavax offer.
With catalysts to come, including the first wave of regulatory approvals, submission to the FDA and delivery of 100 million doses, Mamtani believes the recent stock pullback is “another attractive entry point.”
As a result, the analyst reiterated a buy rating on NVAX, supported by a price target of $ 305. There is good potential of 105% from current levels. (To concern Mamtani’s achievements, Click here)
The average street target is only slightly less bullish; at $ 290.33, the figure implies stocks will gain 105% in muscle over the next 12 months. With 2 additional buy odds added to the pot, the stock qualifies with a strong buy consensus odds. (See the analysis of NVAX shares)
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Disclaimer: The opinions expressed in this article are solely those of the analyst presented. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
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