Novavax Rekindles Positive Momentum With RSV and Gates Grant

By Chris Lange Published Sep 29, 9:55AM EDT

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Novavax Inc. (NASDAQ: NVAX), like many other companies in its sector, has suffered over the past couple months in the market pullback. However the company is still very much up on the year, and there appears to be more positive momentum with the release of a recent study and a resulting grant.

The company announced positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) to protect infants via maternal immunization.

The purpose of the Phase 2 trial was to evaluate the safety and immunogenicity of the RSV F Vaccine in healthy pregnant women. The trial also assessed the transplacental transfer of maternal antibodies induced by the vaccine, the impact of maternal immunization on infant safety during the first year of life and RSV-specific antibody levels through the infants’ first six months of life.

At the same time, Novavax was awarded a grant of up to $89 million by the Bill & Melinda Gates Foundation to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women, planned to initiate during the first quarter of 2016.

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This grant will also support regulatory licensing efforts, providing a path to WHO prequalification. Upon licensure, Novavax has agreed to make the RSV F Vaccine affordable and accessible to people in the developing world.

Stanley C. Erck, president and CEO of Novavax, said:

These data illustrate the promise of our RSV F Vaccine to protect infants via maternal immunization, demonstrating robust immune responses in women with antibody transfer to infants. We look forward to advancing our maternal immunization program to a Phase 3 clinical trial with the support of the Bill & Melinda Gates Foundation. We have now delivered positive top-line data from multiple clinical trials this quarter, including two from our RSV F Vaccine program. These announcements are not only significant achievements for our company, but important contributions to the field. We look forward to sustaining this momentum in the coming months, as we intend to initiate two pivotal Phase 3 trials.

So far in 2015, shares of Novavax have outperformed the market and the stock is up 37% year to date, while over the past 52 weeks shares are up nearly 95%.

Shares of Novavax were down 6.5% Tuesday morning, at $7.62 on its 52-week trading range of $3.92 to $15.01. The stock has a consensus analyst price target of $17.14.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.