We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Novavax (NVAX) Stock Surges YTD as COVID Vaccine Advances Well
Read MoreHide Full Article
Shares of Novavax, Inc. (NVAX - Free Report) have skyrocketed 117.2% this year so far compared with the industry’s 0.8% rise.
Image Source: Zacks Investment Research
This rally in share price is primarily being driven by the company’s potential COVID-19 vaccine candidate NVX-CoV2373. The COVID vaccine was found to be effective against strains of the coronavirus first found in the United Kingdom, the United States, Brazil, South Africa and India.
COVID-19 Vaccine
The vaccine is developed using Novavax’s proprietary nanoparticle technology and is advancing well in the late-stage studies.
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 met 100% protection against moderate and severe disease, which indicates a key secondary endpoint.
NVX-CoV2373 is also being evaluated in adolescents aged between 12 years and less than 17 years.
Novavax continues to analyze its COVID-19 boosters in the ongoing phase II study, which is evaluating NVX-CoV2373 in the United States and Australia in selected participants to examine the functional immune response. In May, the company announced data from this study, which demonstrated that a single booster dose of the coronavirus elicited a 4.6-fold increase in the functional antibody titers. The booster dose was administered six months after an initial two-dose regimen.
The company also signed agreements with various other countries including Australia, Canada and South Korea for supplying its COVID vaccine. Novavax partnered with the Serum Institute of India to produce 1.1 billion doses of its COVID vaccine. The company also filed regulatory filings for the emergency use of its vaccine in multiple markets including India, Indonesia and the Philippines.
Novavax anticipates filing regulatory applications for the emergency use of NVX-CoV2373 in the United States during fourth-quarter 2021, and in the United Kingdom and the EU during third-quarter 2021.
However, if approved, NVX-CoV2373 will face stiff competition from the COVID vaccines developed by AstraZeneca (AZN - Free Report) , Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech, which are already in the market.
Other Vaccines
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 the phase III studies.
The company also 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 a phase II and phase I study to address older adults and the pediatric patient population, respectively, for the given indication.
Last week, the company initiated the patient enrollment in a phase I/II study to evaluate a combination of its COVID-19 vaccine candidate and the seasonal influenza vaccine candidate.
While the lack of any marketable drug in the company’s portfolio remains a woe, Novavax’s pipeline progress keeps its stock afloat. A potential approval of any of the pipeline candidates will boost both the stock price and the revenue prospects of Novavax.
Image: Shutterstock
Novavax (NVAX) Stock Surges YTD as COVID Vaccine Advances Well
Shares of Novavax, Inc. (NVAX - Free Report) have skyrocketed 117.2% this year so far compared with the industry’s 0.8% rise.
Image Source: Zacks Investment Research
This rally in share price is primarily being driven by the company’s potential COVID-19 vaccine candidate NVX-CoV2373. The COVID vaccine was found to be effective against strains of the coronavirus first found in the United Kingdom, the United States, Brazil, South Africa and India.
COVID-19 Vaccine
The vaccine is developed using Novavax’s proprietary nanoparticle technology and is advancing well in the late-stage studies.
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 met 100% protection against moderate and severe disease, which indicates a key secondary endpoint.
NVX-CoV2373 is also being evaluated in adolescents aged between 12 years and less than 17 years.
Novavax continues to analyze its COVID-19 boosters in the ongoing phase II study, which is evaluating NVX-CoV2373 in the United States and Australia in selected participants to examine the functional immune response. In May, the company announced data from this study, which demonstrated that a single booster dose of the coronavirus elicited a 4.6-fold increase in the functional antibody titers. The booster dose was administered six months after an initial two-dose regimen.
The company also signed agreements with various other countries including Australia, Canada and South Korea for supplying its COVID vaccine. Novavax partnered with the Serum Institute of India to produce 1.1 billion doses of its COVID vaccine. The company also filed regulatory filings for the emergency use of its vaccine in multiple markets including India, Indonesia and the Philippines.
Novavax anticipates filing regulatory applications for the emergency use of NVX-CoV2373 in the United States during fourth-quarter 2021, and in the United Kingdom and the EU during third-quarter 2021.
However, if approved, NVX-CoV2373 will face stiff competition from the COVID vaccines developed by AstraZeneca (AZN - Free Report) , Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech, which are already in the market.
Other Vaccines
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 the phase III studies.
The company also 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 a phase II and phase I study to address older adults and the pediatric patient population, respectively, for the given indication.
Last week, the company initiated the patient enrollment in a phase I/II study to evaluate a combination of its COVID-19 vaccine candidate and the seasonal influenza vaccine candidate.
While the lack of any marketable drug in the company’s portfolio remains a woe, Novavax’s pipeline progress keeps its stock afloat. A potential approval of any of the pipeline candidates will boost both the stock price and the revenue prospects of Novavax.
Novavax, Inc. Price
Novavax, Inc. price | Novavax, Inc. Quote
Zacks Rank
Novavax currently carries a Zacks Rank #3 (Hold). You can seethe complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.