Novavax’s COVID-19 Vaccine under EMA’s Review for CMA; Shares Rise

The biotechnology company Novavax, Inc. (NVAX) has been in the headlines due to news related to its COVID-19 vaccine. Shares of the company rose 1.7% in the extended trading session on Wednesday after closing almost 8% higher on the day.

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Novavax disclosed that European Medicines Agency (EMA) has started the evaluation of the application for conditional marketing authorization (CMA) for its COVID-19 vaccine. The vaccine will be marketed in the European Union under the brand name Nuvaxovid.

The CEO of Novavax, Stanley C. Erck, said, “Today’s announcement from EMA brings Novavax another step closer to our goal of ensuring broad global access to our protein-based COVID-19 vaccine across Europe. Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program.”

Earlier this month, the company completed the submission of all data and modules as required by the EMA for regulatory evaluation of NVX-CoV2373, Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. EMA has indicated that its assessment will proceed under an accelerated timeline.

Authorization in the Philippines

In a separate release, Novavax and Serum Institute of India Pvt. Ltd. (SII) have revealed that NVX-CoV2373 has been authorized for emergency use by the Philippine Food and Drug Administration (FDA) for individuals 18 years of age and older.

The regulator’s decision was based on the data from the Phase 3 clinical trial, which reflected a favorable efficacy and safety profile. The vaccine will be manufactured and marketed in the Philippines by SII, the largest vaccine manufacturer by volume globally, under the brand name COVOVAX.

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Erck said, “With less than a third of the Philippine population fully immunized, we expect the option for a protein vaccine, built on a well-understood technology platform, to contribute substantially to increased vaccination rates. Novavax looks forward to SII’s delivery of the vaccine to the Philippines, and with additional authorizations expected elsewhere soon, to helping control the COVID-19 pandemic around the globe.”

Other Details

Markedly, Novavax and SII have recently received EUA in Indonesia, and filed for the same in India, along with Emergency Use Listing (EUL) with the World Health Organization (WHO). (See Novavax stock charts on TipRanks)

Additionally, Novavax has completed rolling submissions for the authorization of the Novavax vaccine with regulatory agencies in the United Kingdom, European Union, Canada, Australia and with the WHO. Furthermore, submission of the complete package to the U.S. Food and Drug Administration (FDA) is expected by the end of the year.

Wall Street’s Take

Following the company’s updates, B.Riley Financial analyst Mayank Mamtani maintained a Buy rating on the stock with a price target of $305 (65.77% upside potential).

Mamtani said, “We continue to believe the EUA path remains open with U.S. FDA with multi-faceted strategic objectives attained, notably (1) offering a choice to the unvaccinated (including pediatrics subsequently) of a more conventional protein-based vaccine product; (2) policy support for use as boosters given increased comfort with mix-and-match; and (3) vaccine diplomacy particularly to support hard-hit regions with persistently low vaccination rates.”

The rest of the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on 2 Buys and 1 Hold. The average Novavax price target of $249.67 implies 35.7% upside potential to current levels. Shares have rallied 104.6% over the past year.

Risk Analysis

According to the new TipRanks’ Risk Factors tool, the Novavax stock is at risk mainly from three factors: Tech and Innovation, Legal and Regulatory and Finance and Corporate, which contribute 26%, 23% and 21%, respectively, to the total 57 risks identified for the stock.