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Novavax Reports Fourth Quarter and Year-End 2014 Financial Results
Gaithersburg, MD (February 26, 2015) - Novavax, Inc., (Nasdaq: NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced its financial results for the fourth quarter and twelve months ended December 31, 2014.
Fourth Quarter and Subsequent Achievements:
|·||Initiated a Phase 2 clinical trial of its RSV F-Protein nanoparticle vaccine candidate (RSV F Vaccine) in 1,600 elderly adults (≥60 years of age);|
|·||Received the U.S. Food and Drug Administration’s (FDA) Fast Track Designation of our RSV F Vaccine for protection of infants via maternal immunization, which, among other advantages, provides the potential for priority review (shorter Biologics License Application review) that could result in improved timeline to licensure;|
|·||Initiated enrollment in a Phase 1 clinical trial of our RSV F Vaccine in healthy children, the first study of this vaccine candidate to be conducted in a pediatric population; and|
|·||Presented new positive data from the first clinical study of our RSV F Vaccine in women of childbearing age at the 8th Vaccine & ISV Congress, showing 50% reduction in infection in the vaccinated women relative to placebo. This data suggests that the vaccine may be efficacious in future clinical testing.|
|·||Initiated a randomized, observer-blinded, dose-ranging Phase 2 clinical trial of our recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP) in 400 healthy adults. This trial is being conducted under our contract with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) (Contract No. HHSO 100201100012C) for the development of Novavax’ recombinant vaccines to address seasonal influenza and influenza strains with pandemic potential; and|
|·||Received the FDA’s Fast Track Designation of our Pandemic H7N9 Influenza VLP vaccine candidate (Pandemic H7N9 VLP) with Matrix-M™ adjuvant, which recognizes the public health risks of the H7N9 strain and may allow for an improved timeline to licensure via the potential for accelerated approval and priority review.|
|·||Initiated a novel Ebola Glycoprotein (GP) recombinant nanoparticle vaccine candidate (EBOV GP Vaccine) program based on the currently circulating Makona strain (previously referred to as the Guinea strain) of Ebola virus;|
The following information was filed by Novavax Inc (NVAX) on Friday, February 27, 2015 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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