Biotechnology company Novavax, Inc.’s (NASDAQ: NVAX) COVID-19 vaccine NVX-CoV2373 or Nuvaxovid has been granted conditional marketing authorization (CMA) by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) for use in adults.
Additionally, New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has given provisional approval to Nuvaxovid for active immunization in adults.
Both the approvals are based on two pivotal Phase 3 clinical trials in which the vaccine demonstrated efficacy and reassuring safety and tolerability profile.
Initially, the Serum Institute of India will supply the vaccine to New Zealand.
Novavax plans to supplement the provisional approval, received in New Zealand, with data from additional manufacturing facilities in its supply chain.
The company had earlier announced that it has an agreement with the U.K. Vaccines Taskforce to supply up to 60 million doses of the vaccine. It had also revealed an advance purchase agreement with the New Zealand government for 10.7 million doses of Nuvaxovid.
Maryland-based Novavax develops, manufactures and sells next-generation vaccines for serious infectious diseases.
NVX-CoV2373 has provisional registration in Australia, conditional marketing authorization in the EU, and has received an emergency use listing (EUL) from the WHO. It is also being reviewed by several regulatory agencies across the world, including the U.S. FDA.
Following both the announcements after the market closed on Thursday, NVAX stock jumped 4.4% to end the day at $92.37.
Wall Street’s Take
Recently, B.Riley Financial analyst Mayank Mamtani maintained a Buy rating on the stock with a price target of $315 (256% upside potential).
Last month, Georgi Yordanov of Cowen & Co. initiated coverage of Novavax with a Buy rating and $150 price target (69.5% upside potential).
In a research note to investors, Yordanov said, “The company is entering the competitive COVID-19 vaccine market with a differentiated profile and improved tolerability compared to the mRNA options.”
Overall, the stock has a Strong Buy consensus rating based on 4 Buys and 1 Hold. The average NVAX price target of $243.60 implies 175.3% upside potential. Shares have lost 59.3% over the past six months.
TipRanks data shows that financial blogger opinions are 73% Bullish on Novavax, compared to the sector average of 70%.
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