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, Inc. (Nasdaq: NVAX) announced that its protein-based COVID-19 vaccine, NVX-CoV2373, has received full product registration with conditions from the South African Health Products Regulatory Authority. This two-dose vaccine is authorized for use in adults aged 18 and older and is marketed as Covovax™. The registration is based on Phase 3 clinical trials, which demonstrated overall efficacy rates of 90.4% and 89.7% in separate studies. The vaccine has also received approvals from over 43 countries, including the U.S. and WHO.
Novavax, Inc. (Nasdaq: NVAX) announced the European Commission's approval of its Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a booster for adults aged 18 and older. This expanded conditional marketing authorization allows the vaccine to be administered regardless of prior vaccination. The approval follows favorable results from multiple Phase 2 trials demonstrating increased immune responses and overall safety. Nuvaxovid is already approved in several other regions, including Japan and Australia, and targets variants, showing efficacy against Omicron strains.
On September 7, 2022, Novavax (Nasdaq: NVAX) announced its participation in two investor conferences. The discussions will focus on its COVID-19 vaccine, NVX-CoV2373. The first conference, H.C. Wainwright 24th Annual Global Investment Conference, is scheduled for September 12, 2022, from 4:00 to 4:30 p.m. EDT at Lotte New York Palace Hotel. The second, Baird 2022 Global Healthcare Conference, will take place on September 13, 2022, from 8:30 to 9:00 a.m. EDT at Intercontinental New York Barclay Hotel. Recordings of the sessions will be available on Novavax's website for 90 days.
Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 vaccine, Nuvaxovid™, has been recommended for expanded conditional marketing authorization (CMA) in the EU as a homologous and heterologous booster for adults 18 and older. This recommendation by the CHMP is based on data from Phase 2 trials conducted in Australia, South Africa, and the UK. Nuvaxovid has already been approved in Japan, Australia, and New Zealand. As the pandemic evolves, Novavax aims to enhance global access to diversified vaccine options.
Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 vaccine, Nuvaxovid™, received expanded conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency for use in adolescents aged 12 to 17. This marks the first protein-based COVID-19 vaccine available for this age group in the UK. The authorization is based on data from the pediatric expansion of the Phase 3 PREVENT-19 trial, where Nuvaxovid demonstrated 80% clinical efficacy during the Delta variant surge. The next step involves a policy recommendation from the UK Joint Committee on Vaccination and Immunisation.
Novavax, Inc. (Nasdaq: NVAX) announced the FDA has granted expanded emergency use authorization for its COVID-19 Vaccine, Adjuvanted for adolescents aged 12-17. This marks it as the first protein-based COVID-19 vaccine authorized in the U.S. A clinical trial involving 2,247 participants demonstrated an overall efficacy of 78.29% against the Delta variant. Vaccination immunizations for adolescents can start following CDC recommendations. Safety data indicates a well-tolerated profile with mild side effects. The vaccine remains authorized under EUA and is designed to enhance vaccination rates as COVID-19 cases surge.
Novavax, Inc. (Nasdaq: NVAX) announced that New Zealand's Medsafe has granted expanded provisional approval for Nuvaxovid™, a protein-based COVID-19 vaccine, for adolescents aged 12 to 17. This approval allows Nuvaxovid to be used as a primary series and booster for older populations. The decision is based on the Phase 3 PREVENT-19 trial, which showed an 80% clinical efficacy during the Delta variant's prevalence. The vaccine was well-tolerated, with low serious adverse events. Nuvaxovid is already authorized in several countries for this age group, enhancing global vaccination efforts.
Novavax announced that its COVID-19 vaccine, Nuvaxovid™, has received expanded provisional approval from New Zealand's Medsafe. This approval allows Nuvaxovid to be used as both a first and second booster dose for adults aged 18 and older, regardless of the primary vaccine received. As New Zealand faces a surge of COVID-19 cases, Novavax emphasizes its vaccine’s broad immune response to circulating variants. The approval is supported by data from several Phase 2 trials, demonstrating strong immune responses post-booster. Nuvaxovid is also provisionally registered in Australia and approved in Japan.
Novavax has submitted an application to the U.S. FDA for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted, as a booster for adults 18 and older. If approved, it would be the first protein-based booster available, complementing immunity from other vaccines. Data from the Phase 3 PREVENT-19 trial indicates that the booster dose generates robust antibody responses. The vaccine aims to enhance immunity against various COVID-19 variants and has previously received EUA for primary vaccination. Robust safety and immune response data back the application.
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