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, in partnership with the Serum Institute of India, has filed for emergency use authorization for its recombinant nanoparticle COVID-19 vaccine in India, Indonesia, and the Philippines. This is the first protein-based COVID-19 vaccine submission to any regulatory body. A submission for World Health Organization Emergency Use Listing is expected in August 2021. The vaccine, NVX-CoV2373, shows high efficacy rates and is designed to be stable in standard cold chain conditions. Novavax and SII are committed to providing over 1.1 billion doses to the COVAX Facility.
Novavax (Nasdaq: NVAX) announced a significant agreement with the European Commission for up to 200 million doses of its COVID-19 vaccine, NVX-CoV2373, including an initial purchase of 100 million doses. Deliveries are set to commence post-approval from the European Medicines Agency, expected in Q3 2021. Clinical trials showed NVX-CoV2373's efficacy at 90.4% against overall infection and 100% against severe disease. This partnership aims to bolster vaccine options for Europe and globally amid the ongoing pandemic.
Novavax, Inc. (Nasdaq: NVAX) will announce its second quarter 2021 financial results and operational highlights on August 5, 2021, at 4:30 p.m. ET. The announcement will be followed by a conference call, accessible at www.novavax.com/events. Notably, Novavax is conducting late-stage clinical trials for its COVID-19 vaccine, NVX-CoV2373, and has achieved positive results with its NanoFlu™ vaccine for influenza, which met all primary objectives in its Phase 3 trial.
Novavax, Inc. (Nasdaq: NVAX) released the final analysis of its pivotal Phase 3 clinical trial for the COVID-19 vaccine NVX-CoV2373, published in the New England Journal of Medicine. The trial demonstrated an overall efficacy of 89.7% against all strains and 96.4% against non-B.1.1.7 variants. Conducted in the UK with over 15,000 participants, the study confirmed the vaccine's strong safety and efficacy profile, highlighting its potential in combating COVID-19. The results align closely with previous trial data, reinforcing confidence in NVX-CoV2373's role in the pandemic response.
Novavax, Inc. (Nasdaq: NVAX) announced participation in the 2nd Annual CybeRx Series: Vaccine Forum on June 22, 2021. The fireside chat will feature discussions around NVX-CoV2373, Novavax's recombinant nanoparticle protein-based COVID-19 vaccine. The event will be moderated by Geoffrey Porges, with Novavax leaders Gregory M. Glenn and John J. Trizzino participating. This forum highlights Novavax's innovative approach to vaccine development, particularly in combating serious infectious diseases.
Novavax, a biotechnology company, announced that Gregory M. Glenn, M.D., its President of Research and Development, will participate in a session at the National Vaccine Advisory Committee meeting on June 17, 2021. The discussion will focus on Novavax' COVID-19 vaccine candidate, NVX-CoV2373. The session is scheduled from 3:15 p.m. to 4:15 p.m. ET, titled Experiences in the Field: COVID-19 Vaccine Authorization and Beyond. Novavax is advancing its vaccine to combat SARS-CoV-2, aiming to enhance global health through innovative vaccines.
Novavax (Nasdaq: NVAX) announced promising results from its first co-administration study of its COVID-19 vaccine candidate, NVX-CoV2373, alongside an influenza vaccine. Conducted in the UK with 431 volunteers, the study showed vaccine efficacy rates of 87.5% for the co-administered group and 89.8% for the main study. The findings suggest that simultaneous vaccination could enhance public health efforts by reducing healthcare visits. The vaccine demonstrated a favorable safety profile, with mild reactogenicity and preserved immunogenicity for the influenza vaccine.
Novavax, Inc. (Nasdaq: NVAX) reported promising results from its PREVENT-19 Phase 3 trial for the COVID-19 vaccine NVX-CoV2373. The vaccine demonstrated 100% efficacy against moderate and severe disease and an overall efficacy of 90.4%, achieving its primary endpoint. The study involved 29,960 participants across the U.S. and Mexico. Novavax plans to apply for regulatory approvals in Q3 2021 and expects to manufacture 100 million doses per month by the end of Q3. The vaccine showed strong efficacy against Variants of Interest and Concern.
Novavax, Inc. (Nasdaq: NVAX) announced promising data on its COVID-19 vaccine candidate, NVX-CoV2373, against the SARS-CoV-2 Beta variant. Recent studies show strong immunogenicity and protection against both Alpha and Beta variants. Results indicated that booster doses of a variant-directed vaccine could enhance immune responses significantly. Notably, mice and baboons demonstrated robust antibody responses, and human trials have shown neutralizing capacity against variants. Further clinical testing is expected to commence in Fall 2021, indicating the potential for broader vaccine protection.
Novavax (NASDAQ: NVAX) will host Maryland Governor Larry Hogan on June 10, 2021, at its future Vaccines Innovation Campus in Gaithersburg. The event at 9:30 AM ET will include a tour and press briefing led by CEO Stanley C. Erck and Greg Glenn, M.D. This follows approval by Gaithersburg's city officials for expansion, enhancing R&D and manufacturing capabilities. Novavax aims to grow its presence in Maryland’s biotech sector while advancing its COVID-19 vaccine and other projects.
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