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.
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.
Novavax (NVAX) has reached an agreement with the Canadian government to supply up to 76 million doses of its COVID-19 vaccine, NVX-CoV2373, set to start in the second quarter of 2021. The deal aims to ensure broad access to the vaccine, which is currently in multiple Phase 2 clinical trials, including a Phase 2b trial in South Africa. NVX-CoV2373 utilizes Novavax's proprietary Matrix-M™ adjuvant to enhance immune responses. The agreement will finalize subject to Health Canada's licensure of the vaccine.
Novavax (Nasdaq: NVAX) announced the enrollment of first volunteers in the Phase 2 clinical trial of its COVID-19 vaccine candidate, NVX-CoV2373. This trial aims to assess immunogenicity and safety, expanding the age range to include participants aged 60-84 years, who constitute about 50% of the trial population. The trial will enroll up to 1,500 volunteers across the U.S. and Australia, with preliminary efficacy evaluations as a secondary objective. Interim data is expected in Q4 2020, following encouraging Phase 1 results that showed robust antibody responses.
Novavax, Inc. (NASDAQ: NVAX) has announced the initiation of a Phase 2b clinical trial in South Africa for its COVID-19 vaccine candidate NVX-CoV2373. The trial, led by Professor Shabir Madhi, aims to assess the vaccine's efficacy with a $15 million grant from the Bill & Melinda Gates Foundation. Approximately 2,665 healthy adults and 240 medically stable, HIV-positive adults will participate. The trial infrastructure and seasonal COVID-19 transmission could allow for rapid evaluation of efficacy. If successful, the vaccine may be supplied to South Africa through Novavax's collaboration with the Serum Institute of India.
Novavax has signed an agreement with the UK government to supply 60 million doses of its COVID-19 vaccine, NVX-CoV2373, starting in Q1 2021. The partnership includes collaboration with FUJIFILM Diosynth Biotechnologies to manufacture the vaccine's antigen in the UK, with a capacity of up to 180 million doses annually. A Phase 3 clinical trial will assess the vaccine's efficacy, involving approximately 9,000 adults, slated to begin in Q3 2020. Novavax has received $2 billion in funding for its global vaccine program.
AGC Biologics has expanded its partnership with Novavax (NASDAQ: NVAX), enhancing the production of Matrix-M, the adjuvant for Novavax's coronavirus vaccine, NVX-CoV2373. The manufacturing will occur at AGC's facilities in Seattle and Copenhagen to ensure adequate supply for the U.S. and global markets. This development supports Novavax's urgent need to enhance vaccine availability in 2020 and 2021. Both companies acknowledge the critical role AGC plays in the supply chain for the coronavirus vaccine.
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