Business
Novavax Reports Fourth Quarter and Full Year 2019 Financial Results
NanoFlu top-line data from Phase 3 clinical trial expected by the end of this monthNovavax awarded CEPI funding to support COVID-19 vaccine programCOVID-19
About this update from Novavax, Inc.
[{"type":"text","content":"NanoFlu top-line data from Phase 3 clinical trial expected by the end of this monthNovavax awarded CEPI funding to support COVID-19 vaccine programCOVID-19 Phase 1 clinical trial expected to initiate in late spring of 2020Company to host conference call today at 4:30 p.m. ET GAITHERSBURG, Md., March 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2019.\n “We remain on track to announce top-line results from our pivotal Phase 3 clinical trial for NanoFlu by the end of this month. Positive clinical data from this trial would support a subsequent U.S. BLA using the FDA’s accelerated approval pathway,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We continue to make progress towards partnering our ResVax program and recently announced progress in our efforts to develop a vaccine against COVID-19, with the goal of moving one or more optimized COVID- 19 candidates into the clinic by the end of this spring.” Fourth Quarter 2019 and Subsequent Operational Highlights NanoFlu™ Program Results of the pivotal Phase 3 clinical trial for NanoFlu, Novavax’ recombinant quadrivalent seasonal influenza vaccine candidate, are expected later this month. The trial includes 2,652 healthy older adults across 19 U.S. clinical sites. The primary objective of the randomized, observer-blinded, active-controlled trial is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains and safety compared against a licensed vaccine, Fluzone® Quadrivalent. Positive top-line results from this Phase 3 clinical trial would support a subsequent U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway. In addition, in January 2020, the FDA granted Fast Track designation for NanoFlu. COVID-19 Program Novavax recently announced that the Coalition for Epidemic Preparedness Innovations (CEPI) awarded an initial funding of $4 million to support its effort to develop a COVID-19 vaccine. CEPI and Novavax are having ongoing discussions on addition...