Back to top

Image: Shutterstock

Novavax (NVAX) COVID Jab Gets Philippines Nod, Under Review in EU

Read MoreHide Full Article

Shares of Novavax (NVAX - Free Report) rose 7.9% on Nov 18, after the company announced that it clinched the emergency use authorization (EUA) for its COVID-19 vaccine NVX-CoV2373 in the Philippines.

The vaccine will be manufactured and marketed in the Philippines by the Serum Institute of India under the brand name Covovax.

Earlier this month, the company received EUA for its COVID vaccine in Indonesia.

The stock has rallied 65% so far this year against the industry’s 14.3% decline.

Zacks Investment ResearchImage Source: Zacks Investment Research

In a separate press release issued after the close of marketing hours on Nov 17, Novavax announced that the European Medicines Agency (EMA) started reviewing its conditional marketing authorization (CMA), seeking approval for Novavax's COVID-19 vaccine NVX-CoV2373. The vaccine will be marketed under the brand name Nuvaxovid.

The EMA indicated that it will assess the CMA under an accelerated timeline. Since the EMA already reviewed a substantial portion of the data on the vaccine, the regulatory body expects to issue an opinion on the same in a few weeks’ time. Shares of the company rose 5.4% in after-hours trading, probably following this news.

Earlier in November, management had announced that it completed the submission of all the data and modules required by the EMA for the regulatory evaluation of Novavax’s COVID vaccine.  

Novavax completed the rolling submission for the Emergency Use listing of its COVID vaccine candidate with the World Health Organization (WHO) in November 2021.

Regulatory filings for the EUA of NVX-CoV2373 were also submitted in multiple markets, including Australia, Canada, the EU, India, New Zealand and the United Kingdom. Last week, Novavax filed a regulatory application in South Korea seeking full approval for its COVID vaccine.

While Novavax’s COVID vaccine NVX-CoV2373 holds a strong potential to cater to the requirement of several billion doses across the globe, the multiple delays in the regulatory filings for its COVID vaccine across the United States do not bode well for the stock. The company reiterates its plans to apply to the FDA in fourth-quarter 2021 for the EUA of NVX-CoV2373.

Zacks Rank & Stocks to Consider

Novavax currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are GlaxoSmithKline (GSK - Free Report) , Precision BioSciences (DTIL - Free Report) and Synlogic (SYBX - Free Report) . While Precision BioSciences sports a Zacks Rank #1 (Strong Buy), both GlaxoSmithKline and Synlogic carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.79 in the past 30 days. The same for 2022 has narrowed from $2.39 to $2.04 in the past 30 days. Shares of Precision BioSciences have rallied 16.9% in the year so far.

Earnings of Precision BioSciences’ beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average.

GlaxoSmithKline’s earnings estimates per share for 2021 have increased from $2.82 to $3.04 in the past 30 days. The same for 2022 has increased from $3.08 to $3.26 in the past 30 days. Shares of Glaxo have risen 15.7% in the year so far.

Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed expectations on one occasion, delivering a surprise of 15.3%, on average.

Synlogic’s loss per share estimates for 2021 have narrowed from $1.22 to $1.18 in the past 30 days. The same for 2022 has narrowed from $1.19 to $1.07 in the past 30 days. Shares of Synlogic have gained 23.2% in the year so far.

The bottom line of Synlogic beat estimates in three of the last four quarters and met expectations once, delivering a surprise of 3.41%, on average.

Published in