Shares of Novavax Inc. (NAS:NVAX) shot up 6.8% in premarket trading Monday, after the biotechnology company said it has completed its rolling submission to Canada's health authorities, Health Canada, for the authorization of its COVID-19 vaccine candidate. The company said it has also completed the submission of all data to the European Medicines Agency (EMA) for regulatory review. The company said the final step for applying for EMA authorization is an invitation from EMA to file for Conditional Marketing Authorization. "Novavax continues to deliver regulatory filings that we expect will bring the first protein-based COVID-19 vaccine based on Phase 3 data to the world," said Novavax Chief Executive Stanley Erck. "We thank the Government of Canada and the European Commission for their ongoing partnership and confidence in our COVID-19 vaccine program." The stock has tumbled 17.0% over the past three months through Friday, while the iShares Biotechnology ETF (NAS:IBB) has slipped 3.7% and the S&P 500 (S&P:SPX) has gained 4.8%.
Nov. 1, 2021, 6:29 a.m. EDT