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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 the presentation of its COVID-19 vaccine, NVX-CoV2373, at the virtual 2020 World Vaccine Congress Europe from October 19-21, 2020. Gregory M. Glenn, M.D., President of Research & Development, will discuss the recombinant nanoparticle vaccine platform. NVX-CoV2373 is engineered from the SARS-CoV-2 genetic sequence and incorporates Novavax's Matrix-M™ adjuvant to enhance immune response. The vaccine has shown promising results in preclinical trials and is in Phase 1 and Phase 3 clinical evaluations, supported by $2 billion in funding for its global vaccine program.
Novavax, Inc. (Nasdaq: NVAX) has formed a leadership team aimed at advancing its NanoFlu vaccine towards global licensure. Russell (Rip) Wilson has been promoted to Executive Vice President and NanoFlu General Manager, focusing on regulatory approvals for NanoFlu and a potential combined influenza/COVID-19 vaccine. The company intends to file a biologics licensing application (BLA) for NanoFlu, which has completed a successful Phase 3 trial. The new team includes experienced Novavax veterans to enhance development efforts across its vaccine pipeline.
Novavax (Nasdaq: NVAX) announced participation in four investor and industry conferences to discuss its COVID-19 vaccine candidate, NVX-CoV2373. Key events include the Maryland Life Sciences Bio Innovation Conference and the Guggenheim Vaccines and Infectious Diseases Conference, both on October 5, 2020. The vaccine uses proprietary recombinant nanoparticle technology and has shown promising results in clinical trials, demonstrating robust antibody responses. Novavax has secured $2 billion in funding for its global vaccine initiative, enhancing its position in addressing COVID-19.
Novavax, Inc. (Nasdaq: NVAX) announced its presentations at the 2020 World Vaccine Congress, featuring vaccines NVX-CoV2373, NanoFlu™, and ResVax™. Presenters Gregory Glenn and Vivek Shinde will discuss innovative vaccine development for COVID-19, influenza, and RSV from September 28 to October 1, 2020. Key presentation topics include the recombinant nanoparticle COVID-19 vaccine platform and new data on maternal RSV and influenza vaccines. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, emphasizing its commitment to addressing urgent public health needs.
Novavax, Inc. (Nasdaq: NVAX) announced its participation in the 2020 World Vaccine Congress, presenting updates on its vaccine candidates NVX-CoV2373 (COVID-19), NanoFlu™, and ResVax™. Key presentations include NVX-CoV2373's recombinant nanoparticle technology on September 28 and updates on maternal RSV and influenza vaccine programs on October 1. The company aims to address emerging infectious diseases and has secured significant funding, including $2 billion for its coronavirus vaccine initiatives. Experts from Novavax will collaborate with global leaders in public health during the congress.
On September 24, 2020, Maryland Governor Larry Hogan and BIO President Dr. Michelle McMurry-Heath highlighted Novavax's efforts in vaccine development against COVID-19 during an event at the company’s Gaithersburg facility. Novavax is preparing to initiate three Phase 3 trials for its vaccine candidate, NVX-CoV2373, with global trials in the UK, US, and India. The company's commitment reflects its responsibility to ensure widespread protection against the virus, underscoring the vital role of the biotechnology sector in combating health crises.
Novavax (Nasdaq: NVAX) has initiated its first Phase 3 study of NVX-CoV2373, a COVID-19 vaccine candidate, in the UK, aiming to enroll up to 10,000 participants aged 18-84. This trial explores the vaccine's efficacy, safety, and immunogenicity, with results expected to support regulatory submissions. The vaccine utilizes Novavax's recombinant protein nanoparticle technology and can be stored at standard refrigeration temperatures. Manufacturing capacity is set to reach 2 billion doses annually by mid-2021.
Novavax (Nasdaq: NVAX) has announced a significant agreement with Serum Institute of India to manufacture approximately 1 billion doses of its COVID-19 vaccine candidate, NVX-CoV2373, in 2021. This expands Novavax's global manufacturing capacity to over 2 billion doses annually when fully operational. The agreement establishes a robust supply chain, with production facilities across multiple continents, and supports Novavax's commitment to equitable vaccine distribution. The vaccine is currently in Phase 2 clinical trials, with Phase 3 trials anticipated soon.
Novavax (Nasdaq: NVAX) announced its participation in five investor conferences, highlighting its COVID-19 vaccine candidate NVX-CoV2373. Key events include:
- Citi 15th Annual BioPharma Virtual Conference on September 10, 2020
- H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, 9:30 a.m. ET
- Cantor Virtual Global Healthcare Conference on September 15, 2020, 11:20 a.m. ET
- Morgan Stanley Virtual 18th Annual Global Healthcare Conference on September 16, 2020, 12:30 p.m. ET
- Leerink CyberRx Series: Vaccine Forum on September 23, 2020, 9:00 a.m. ET
Replays will be available on Novavax's website.
Novavax (Nasdaq: NVAX) announced the publication of Phase 1 data for its COVID-19 vaccine candidate, NVX-CoV2373, in The New England Journal of Medicine. The results indicate a strong safety profile and superior antibody responses compared to human convalescent sera. Following positive Phase 1 results, multiple Phase 2 trials commenced in the US, Australia, and South Africa to further evaluate efficacy. The funding for the trial includes support from the Coalition for Epidemic Preparedness Innovations (CEPI). NVX-CoV2373 showcases a favorable product profile, with stability for easy storage.
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