Novavax, Inc. (NASDAQ: NVAX)
Novavax is having a strong day in the market today following yesterday’s declines. However, I have to say that in my opinion, yesterday’s declines were unwarranted. The only news that surfaced with regard to the stock was positive news. First and foremost, the company released positive top-line data from one the Phase 2 study of the RSV F Vaccine. Also, NVAX received incredible support from the Bill & Melinda Gates Foundation. Today, we’ll talk about both of these events, what we’re seeing in the market today, and what we can expect to see moving forward.
NVAX Presents Positive RSV F Phase 2 Data
The Phase 2 trial looking into RSV F was a randomized, blinded, placebo-controlled study which included 50 healthy pregnant women in the third trimester. The women were first randomized, then given either a placebo or 129 micrograms of the RSV F Vaccine adjuvanted with 0.4 mg of aluminum phosphate. The women were then followed through the remainder of their pregnancies, delivery and for an additional 180 days to assess safety and immunogenicity as measured by serum RSV anti-F IgG, microneutralizing, and palivizumab-competing antibody titers.
The women that were vaccinated showed promising results. They demonstrated a geometric mean 14 fold rise in anti-F IgG, a 29 fold rise in PCA, and a 2 fold rise in microneutralization titers. This was then compared to the results from women who received a placebo. The placebo group demonstrated no significant change in their antibody levels. Following the release of the data Stanley C. Erck, President and CEO of Novavax had the following to say…
“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 trails.”
Bill & Melinda Gates Show Support For Novavax
On top of the incredible data produced by Novavax, the company announced that the Bill & Melinda Gates foundation has shown support for their efforts by awarding the company a Grant for the continued development of the RSV F Vaccine. Under the grant, NVAX will receive up to $82 million for the ongoing development of the vaccine. In return, NVAX has agreed that upon licensing, they will make the vaccine available and affordable in the developing world.
What We Can Expect To See Moving Forward
All in all, I am expecting to see overwhelmingly positive news from the stock moving forward. NVAX has shown compelling results with regard to their RSV F Vaccine; which has caught the eye of the Bill & Melinda Gates Foundation. Now, they are headed into two Phase 3 studies and soon enough a NDA will be on its way. These will prove to be positive catalysts for the stock.
What Do You Think?
Where do you think NVAX is headed moving forward? Let us know what you think in the comments below!
[Image Courtesy of the Washington Business Journal]