Novavax Rekindles Positive Momentum With RSV and Gates 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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