Novavax Inc - NVAX STOCK NEWS

Novavax, Inc. (Nasdaq: NVAX) announced the submission of a New Drug Application (NDA) for its COVID-19 vaccine, developed in partnership with Takeda, to Japan's Ministry of Health. This marks the first protein-based COVID-19 vaccine submitted for NDA in Japan. The vaccine, NVX-CoV2373, showed a strong immune response in ongoing trials and has demonstrated over 90% efficacy in pivotal Phase 3 trials. Novavax aims to start distribution in early 2022, pending approval. The company also plans to submit complete data to the U.S. FDA.

Novavax, Inc. (Nasdaq: NVAX) announced the submission of a regulatory filing to the UAE's Ministry of Health and Prevention for the emergency use of its COVID-19 vaccine, NVX-CoV2373. This vaccine demonstrated 100% protection against moderate and severe disease in pivotal U.S.-Mexico trials, with an overall efficacy of 90.4%. The company aims to deliver its vaccine globally, leveraging its partnership with the Serum Institute of India. Novavax also plans to submit a complete package to the U.S. FDA by year-end.

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.