Novavax, Inc.’s ( NVAX Quick Quote NVAX - Free Report) shares have skyrocketed 95.5% this year so far against the industry’s 15.8% decline. Image Source: Zacks Investment Research
This share price rally is primarily being driven by the company’s COVID-19 vaccine, NVX-CoV2373, which has shown to be effective against various strains of coronavirus. Novavax’s COVID vaccine is yet to be launched in the United States and several other countries soon.
The COVID vaccine so developed by the company utilizes its proprietary nanoparticle technology.
Earlier this year in June, the company announced data from the phase III PREVENT-19 study, which evaluated NVX-CoV2373 in the United States and Mexico. The study met its primary endpoint by demonstrating an overall vaccine efficacy of 90.4%. It also showed 100% protection against moderate and severe disease, which was a key secondary endpoint.
NVX-CoV2373 is also being evaluated in adolescents aged between 12 years and less than 17 years.
Novavax is analyzing its COVID-19 vaccine boosters in an ongoing phase II study in the United States and Australia in select participants to examine the functional immune response of the COVID vaccine.
Novavax has partnered with the Serum Institute of India to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX facility. The company will manufacture and distribute 350 million doses to participants of the COVAX facility. The company has also signed advance purchase agreements with different countries for supplying doses of its COVID vaccine.
Earlier this month, the company announced that it received the EUA for its COVID vaccine in Indonesia and the Philippines. The vaccine will be marketed in both these nations under the brand name Covovax by the Serum Institute of India.
During second-half 2021, Novavax has submitted regulatory filings for EUA of NVX-CoV2373 in multiple markets including Australia, Canada, EU, India, New Zealand, Singapore and the United Kingdom. In South Korea, the company is seeking full approval for its COVID vaccine.
The company plans to apply to the FDA for EUA of NVX-CoV2373 in fourth-quarter 2021.
Novavax has also completed the rolling submission for the Emergency Use listing of its COVID vaccine candidate with the World Health Organization in November 2021.
Apart from the COVID vaccine, the company’s vaccine candidates, namely NanoFlu (for seasonal influenza) and ResVax (for respiratory syncytial virus), are also being evaluated in phase III studies.
The company announced positive top-line data from a pivotal phase III study, which demonstrated both the efficacy and the safety of NanoFlu in March 2020. The study met all the primary goals and achieved a statistical significance with the key secondary endpoints. The company will file a regulatory application in the United States shortly.
ResVax is being evaluated in a phase III study to protect infants by immunizing their mothers against the disease. It is also being investigated in phase II and phase I studies to address older adults and the pediatric patient population, respectively, for the given indication.
Earlier in September, the company
initiated patient enrollment in a phase I/II study to evaluate a combination of its COVID-19 vaccine candidate and seasonal influenza vaccine candidate.
While Novavax’s COVID vaccine holds a strong potential to cater to the requirement of several billion doses across the globe, multiple delays in regulatory filings for its COVID vaccine in the United States do not bode well for the stock.
Zacks Rank & Stocks to Consider
Novavax currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include
GlaxoSmithKline ( GSK Quick Quote GSK - Free Report) , IVERIC bio ( ISEE Quick Quote ISEE - Free Report) and Precision BioSciences ( DTIL Quick Quote DTIL - Free Report) . While both GlaxoSmithKline and Precision BioSciences sport a Zacks Rank #1 (Strong Buy), IVERIC biocurrently carries a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank stocks here
GlaxoSmithKline’s earnings estimates per share for 2021 have increased from $2.86 to $3.06 in the past 30 days. The same for 2022 has increased from $3.10 to $3.26 in the past 30 days. Shares of Glaxo have risen 11.5% 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.
Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to $0.65 in the past 30 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 30 days. Shares of Precision BioSciences have risen 6.6% 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.
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.12 in the past 30 days. The same for 2022 has narrowed from $1.17 to $1.10 in the past 30 days. Shares of IVERIC bio have gained 124% in the year so far.
The bottom line of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, delivering a negative surprise of 5.6%, on average.