Welcome to our dedicated page for Novavax news (Ticker: NVAX), a resource for investors and traders seeking the latest updates and insights on Novavax stock.
Novavax, Inc. (NASDAQ: NVAX) is a biotechnology company focused on vaccines, using a platform that combines protein-based nanoparticles with its proprietary Matrix-M® adjuvant. News about Novavax often centers on its COVID-19 vaccine Nuvaxovid™/Nuvaxovid®, its broader infectious disease pipeline, and the progress of key partnerships and collaborations.
Recent announcements highlight Novavax’s collaboration and license agreement with Sanofi, under which Sanofi has taken on lead commercial and regulatory responsibilities for Nuvaxovid in selected markets. News items cover marketing authorization transfers in the European Union and United States, milestone payments to Novavax, and Sanofi’s clinical data on combination vaccine candidates that incorporate Nuvaxovid and Matrix-M. Updates also describe regulatory approvals in markets such as Japan through partner Takeda, triggering additional milestone payments and royalty opportunities.
Investors following NVAX news will see regular coverage of quarterly financial results, revenue composition from product sales, supply sales and licensing and royalty streams, as well as information on Novavax’s site consolidation and cost footprint in Maryland. The company’s communications also describe early-stage research on vaccine candidates for shingles, Clostridioides difficile colitis and respiratory syncytial virus combinations, and the use of Matrix-M in the R21/Matrix-M malaria vaccine developed with Serum Institute of India and Oxford University.
This page aggregates press releases, conference participation announcements, regulatory updates and other material events related to Novavax. Readers can use it to monitor developments in the company’s vaccine programs, partnership milestones, capital structure transactions and strategic transformation as disclosed in public statements.
On Nov 24, 2021, Novavax (Nasdaq: NVAX) announced its submission for interim authorization of its COVID-19 vaccine to the Singapore Health Sciences Authority under the Pandemic Special Access Route. This filing is supported by clinical data from pivotal Phase 3 trials showing 90.4% efficacy and 100% protection against severe disease. The company aims to address obstacles in global vaccination. Novavax has also received Emergency Use Authorization in Indonesia and the Philippines and anticipates submitting a complete package to the U.S. FDA by year-end.
Novavax, a biotechnology company focused on next-generation vaccines, will participate in Evercore ISI's 4th Annual HealthCONx Virtual Conference on December 2, 2021, from 9:15 to 9:35 a.m. ET. The discussion will center on NVX-CoV2373, their protein-based COVID-19 vaccine. Participants include Gregory M. Glenn, M.D., and John J. Trizzino. Investors can access a replay of the fireside chat on Novavax's website for 90 days post-event. Novavax is advancing global health through innovative vaccines and has received Emergency Use Authorization for NVX-CoV2373 in Indonesia and the Philippines.
Novavax announced that the European Medicines Agency (EMA) has started evaluating its application for conditional marketing authorization (CMA) of its COVID-19 vaccine, branded as Nuvaxovid™, in the EU. This move aims to enhance global access to the vaccine. Novavax's NVX-CoV2373 vaccine, developed using a nanoparticle protein-based technology, has shown efficacy rates of up to 100% against moderate to severe disease. The company anticipates that the EMA will provide an opinion within weeks, with ongoing regulatory submissions in various countries including the U.S. and Australia.
Novavax, Inc. (Nasdaq: NVAX) and Serum Institute of India Pvt. Ltd. announced that the Philippine FDA has granted Emergency Use Authorization (EUA) for Novavax's protein-based COVID-19 vaccine, COVOVAX™, which will be produced by SII. The vaccine's approval aims to boost vaccination rates in the Philippines, where less than a third of the population is fully immunized. COVOVAX™ can be stored at standard refrigeration temperatures, facilitating its distribution. Novavax also anticipates additional authorizations globally and plans to submit more filings, including for the U.S. FDA by year-end.
Novavax and SK bioscience have submitted a Biologics License Application (BLA) for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for BLA in South Korea. This submission signifies the first full approval request for the vaccine globally. Novavax aims to provide broad access to the vaccine, with a deal to supply 40 million doses to the South Korean government. The vaccine shows high efficacy in various trials, promising a vital tool in combating COVID-19.
Novavax, Inc. (NASDAQ: NVAX) reported its third-quarter 2021 results with a revenue of $178.8 million, up from $157.0 million year-on-year. The company faced a net loss of $322.4 million or $4.31 per share, compared to a loss of $197.3 million or $3.21 per share last year. Highlights included emergency use authorization for its COVID-19 vaccine in Indonesia and advanced purchase agreements for 20 million doses with the European Commission. Cash reserves as of September 30, 2021, reached $1.9 billion, primarily from advance purchase payments.
On November 4, 2021, Novavax (Nasdaq: NVAX) announced the completion of its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of its COVID-19 vaccine candidate, NVX-CoV2373. This submission includes clinical data from pivotal Phase 3 trials showing 90.4% overall efficacy. The vaccine demonstrated 100% protection against severe disease and has received authorization in Indonesia. Novavax also plans to submit a complete package to the U.S. FDA by year-end to broaden global access through the COVAX Facility.
Novavax has submitted its protein-based COVID-19 vaccine, NVX-CoV2373, for provisional approval to New Zealand's Medsafe, marking a significant step in global vaccine distribution. The submission includes all necessary modules, such as Chemistry, Manufacturing, and Controls (CMC), backed by phase 3 trial data showing 100% protection against moderate and severe disease and 90.4% overall efficacy. With additional regulatory filings in the UK, Australia, and Canada, Novavax is focused on optimizing its global vaccine strategy while thanking the New Zealand government for its partnership.
Novavax, Inc. (Nasdaq: NVAX) and Serum Institute of India have received Emergency Use Authorization (EUA) from Indonesia's National Agency of Drug and Food Control for COVOVAX™, a protein-based COVID-19 vaccine. This marks a significant milestone as it is the first regulatory approval globally for a protein-based COVID-19 vaccine based on Phase 3 clinical data. Novavax expects additional authorizations soon in various countries, including India and the Philippines. The vaccine's stable storage conditions will enhance distribution accessibility in Indonesia.
Novavax, Inc. (Nasdaq: NVAX) has completed its rolling submission to Health Canada for its COVID-19 vaccine candidate, marking the first protein-based vaccine submitted for regulatory review in Canada. Additionally, all required data modules for the European Medicines Agency (EMA) have been submitted. The vaccine, NVX-CoV2373, showed 100% protection against moderate and severe disease and 90.4% efficacy overall in a Phase 3 trial with 30,000 participants. The company aims to file for Conditional Marketing Authorization in the EU and anticipates submitting a complete package to the U.S. FDA by year-end.