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 clinical-stage biotechnology company dedicated to developing vaccines to prevent infectious diseases. Based in Gaithersburg, Maryland, with facilities in Rockville, Maryland, and Uppsala, Sweden, Novavax employs over 300 professionals focused on innovation in vaccine development.
Novavax leverages its proprietary recombinant nanoparticle technology and Matrix-M™ adjuvant to create vaccines that stimulate strong immune responses. The company's product pipeline includes vaccine candidates for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus. Additionally, their pipeline includes preclinical programs targeting various infectious diseases.
Recently, Novavax has made significant strides in COVID-19 vaccine development. The company announced that its Nuvaxovid™ XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) received Emergency Use Listing (EUL) from the World Health Organization (WHO). This listing expedites the regulatory approval process, enabling broader global distribution. The vaccine is also authorized in the U.S. and the European Union and is under review in other markets.
Novavax's updated COVID-19 vaccine can be stored at temperatures between 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying logistics and reducing waste. This vaccine has shown efficacy against multiple variants, including BA.2.86, EG.5.1, and XBB.1.16.6.
In addition to their COVID-19 efforts, Novavax has entered a co-exclusive licensing agreement with Sanofi to enhance the distribution of their standalone adjuvanted COVID-19 vaccine and develop combination vaccines. This partnership highlights the company's commitment to leveraging its technology to address global health challenges.
Financially, Novavax has shown a strong performance with updated financial guidance for 2024. With over $1 billion in potential contract value for advance purchase agreements, Novavax is well-positioned to deliver on its commitments while focusing on expanding its product portfolio.
Overall, Novavax Inc. represents a significant player in the biotechnology sector, continuously pushing the boundaries of vaccine development to address pressing global health issues.
Novavax (Nasdaq: NVAX) has expanded its collaboration with SK bioscience to enhance the manufacturing of its COVID-19 vaccine, NVX-CoV2373. The agreement allows SK bioscience to reserve additional manufacturing capacity through 2022, supporting a previously made agreement to supply 40 million doses to the Korean government. SK bioscience is also now authorized to sell NVX-CoV2373 to Thailand and Vietnam. Novavax anticipates a total global manufacturing capacity of 2 billion doses in 2022, demonstrating its commitment to increasing vaccine access globally.
Novavax announced promising results for its COVID-19 vaccine NVX-CoV2373 regarding cross-reactive immune responses against the Omicron variant. A two-dose regimen demonstrated effective immune responses, which were enhanced with a third booster dose, showing a 9.3-fold increase in anti-spike IgG and 19.9-fold increase in ACE2 inhibition. Immune responses in adolescents surpassed those in adults. The development of an Omicron-specific vaccine is on track for GMP manufacturing in January 2022. An investor conference call will be held today.
On December 21, 2021, Novavax (Nasdaq: NVAX) announced the administration of the first booster doses of its COVID-19 vaccine, NVX-CoV2373, in an extension of the PREVENT-19 Phase 3 clinical trial. This trial evaluates the safety and efficacy of a third booster dose administered to prior participants, at least six months after their initial vaccinations. The primary endpoint focuses on the first occurrence of PCR-confirmed COVID-19 at least seven days post-booster. NVX-CoV2373 has shown 90.4% efficacy in the PREVENT-19 trial.
WHO SAGE recommends a primary two-dose vaccination series of NVX-CoV2373 for individuals 18 and older. An additional third dose is advised for immunocompromised persons. This follows the Emergency Use Listing granted by WHO for Novavax's vaccine, branded as Nuvaxovid™ in Europe and COVOVAX™ in India. Novavax's trials have shown high efficacy, with overall efficacy rates of 89.7% in the UK trial and 90.4% in the US trial. The vaccine is anticipated to play a crucial role in the global response to COVID-19.
Novavax Announces WHO Emergency Use Listing for Nuvaxovid™
The World Health Organization has granted a second Emergency Use Listing (EUL) for Novavax's NVX-CoV2373 COVID-19 vaccine, branded as Nuvaxovid™, for individuals aged 18 and older. This follows a conditional marketing authorization from the European Commission and facilitates exports to COVAX member countries. Novavax and the Serum Institute of India have committed to supply 1.1 billion doses to COVAX. The vaccine demonstrated high efficacy in Phase 3 trials, providing a protein-based option against COVID-19 variants.
Novavax (Nasdaq: NVAX) received conditional marketing authorization from the European Commission for its Nuvaxovid™ COVID-19 vaccine. This represents the first protein-based COVID-19 vaccine approved for use in Europe, following a positive recommendation from the European Medicines Agency. An advance purchase agreement allows for up to 200 million doses through 2023, with initial supply expected in January. The vaccine demonstrated strong efficacy in pivotal Phase 3 trials, achieving 90.4% efficacy in the U.S. and Mexico, and 89.7% in the U.K.
Novavax (NASDAQ: NVAX) announced an imminent decision from the European Commission regarding the conditional marketing authorization for its COVID-19 vaccine, Nuvaxovid™ (NVX-CoV2373). This would make it the first protein-based COVID-19 vaccine available in Europe. The EMA's recommendation was based on positive clinical trial results, including a 90.4% efficacy rate in a trial with nearly 30,000 participants in the U.S. and Mexico. An advance purchase agreement for up to 200 million doses has already been established with the European Commission.
Novavax (Nasdaq: NVAX) announced that the World Health Organization (WHO) has granted Emergency Use Listing (EUL) for NVX-CoV2373, its protein-based COVID-19 vaccine, marketed as COVOVAX™ by the Serum Institute of India (SII). This EUL allows the vaccine to be distributed globally, particularly to lower-income countries via the COVAX Facility. The WHO's EUL confirms that the vaccine meets its standards for quality, safety, and efficacy. Additionally, the vaccine demonstrated high efficacy in pivotal Phase 3 trials, with 90.4% efficacy in the U.S. and Mexico trial, and 89.7% in the U.K.
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.
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