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) has completed its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its protein-based COVID-19 vaccine candidate, NVX-CoV2373, in Australia. This marks the first complete application for a protein-based COVID-19 vaccine in the country. The TGA submission includes data from pivotal Phase 3 trials, demonstrating efficacy rates of 96.4% against the original virus strain and 90.4% overall. Novavax plans further submissions in key markets, including the U.S., U.K., and Europe, with a goal to enhance global access to its vaccine.
Novavax, Inc. has completed its regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its protein-based COVID-19 vaccine, NVX-CoV2373. This marks the first authorization submission for a protein-based COVID-19 vaccine in the U.K. The vaccine demonstrated high efficacy rates of 96.4% against the original virus and 89.7% overall in trials involving ~45,000 participants. Novavax plans to submit to additional global authorities, including the EU, Canada, and Australia, soon, with FDA submission expected by the end of 2021.
Novavax, Inc. (Nasdaq: NVAX) announces it will report its third quarter 2021 financial results on November 4, 2021, post-market close. The company will host a conference call at 4:30 p.m. EDT to discuss its operational highlights. Participants are encouraged to join early for a timely connection. A replay will be available from 7:30 p.m. EDT on the same day until November 11, 2021. Novavax focuses on developing innovative vaccines to combat serious infectious diseases, including COVID-19 and influenza.
Novavax, Inc. (Nasdaq: NVAX) announced that Dr. Vivek Shinde will present at the World Vaccine Congress Europe 2021 on October 20, 2021. The focus will be on the COVID-NanoFlu™ Combination Vaccine, a novel formulation that integrates the company's COVID-19 and NanoFlu™ vaccine candidates using the Matrix-M™ adjuvant.
The session is scheduled from 11:30 a.m. to 12:00 p.m. CET (5:30 a.m. to 6:00 a.m. EDT). For details, visit the Congress website.
On October 4, 2021, Novavax announced key leadership changes to strengthen its vaccine safety and clinical development teams. Dr. Denny Kim was appointed as Senior Vice President and Chief Safety Officer, with a focus on global vaccine safety. Other promotions include Dr. Raburn Mallory as Senior Vice President and Head of Clinical Development, and Dr. Marco Cacciuttolo as Senior Vice President of Process and Analytical Development. These appointments aim to enhance Novavax's capabilities as the company transitions to a commercial-stage organization, particularly in its pursuit of NVX-CoV2373, a COVID-19 vaccine.
On September 29, 2021, Novavax (Nasdaq: NVAX) announced its participation in the upcoming 2021 Maryland Life Sciences Bio Innovation Conference. The company will discuss its recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, during a panel titled Health Equity and Vaccine Confidence. This panel is scheduled for October 4, 2021, from 1:00 to 1:50 p.m. EDT. Notable speakers include Lisa M. Dunkle, M.D. from Novavax, alongside other experts from the Department of Defense and the University of Maryland.
On September 23, 2021, Novavax hosted HM King Carl XVI Gustaf and HM Queen Silvia at its Uppsala facility to discuss the progress of NVX-CoV2373, its COVID-19 vaccine candidate. The visit highlighted Novavax's commitment to global vaccination efforts, with a focus on its patented Matrix-M™ adjuvant, enhancing immune response. NVX-CoV2373 has shown high efficacy in Phase 3 trials, including 100% efficacy against severe disease. Novavax is also advancing its NanoFlu™ vaccine and is committed to addressing urgent global health needs.
Novavax, Inc. (Nasdaq: NVAX) announced the publication of complete results from its pivotal Phase 3 trial of NanoFlu™, a recombinant quadrivalent seasonal influenza vaccine, in The Lancet Infectious Diseases. The trial demonstrated NanoFlu's enhanced immunogenicity and safety compared to a leading influenza vaccine in older adults. The vaccine achieved all primary endpoints, showing significantly improved immune responses, including a 22-66% increase in antibody responses. The findings support NanoFlu's potential efficacy, particularly amid ongoing evaluations for a combination COVID-19-influenza vaccine.
Novavax, Inc. (Nasdaq: NVAX) has submitted a regulatory application for emergency use listing of its recombinant nanoparticle protein-based COVID-19 vaccine to the World Health Organization (WHO) in collaboration with the Serum Institute of India. This submission aims to facilitate equitable vaccine distribution globally, particularly through the COVAX Facility. The vaccine demonstrated high efficacy in pivotal Phase 3 trials, achieving 100% protection against severe disease and 90.4% overall efficacy. The NVX-CoV2373 vaccine is designed to be easily stored and administered, reinforcing Novavax's commitment to combating the pandemic.
Novavax, Inc. (Nasdaq: NVAX) announced its participation in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on September 29, 2021, from 8:40 – 9:10 a.m. EDT. The discussion will feature the company's COVID-19 vaccine candidate, NVX-CoV2373. Key participants include Gregory M. Glenn, M.D., and John J. Trizzino. A replay of the session will be available on the company's website for 90 days. Novavax is advancing its developing vaccines, including NanoFlu™, which is set for regulatory submission.
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