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 the U.S. FDA has placed a clinical hold on its Investigational New Drug (IND) application for COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S. who received the vaccine in January 2023.
The participant reported the SAE in September 2024, after the trial completed in July 2023. Novavax is working with the FDA to provide necessary information and resolve the clinical hold. The company's Chief Medical Officer, Robert Walker, MD, emphasized that safety is their top priority and that causality has not been established for this event. Previous COVID-19 and influenza trials by Novavax have shown no signals for motor neuropathy. The COVID-19 IND for Novavax's COVID-19 vaccine is not affected by this clinical hold.
Novavax announced that the European Commission has granted Marketing Authorization for its updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine for individuals aged 12 and older in the European Union. The authorization follows a positive opinion from the EMA's Committee for Medicinal Products for Human Use. Non-clinical data showed the updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses.
The vaccine is also authorized for use in the U.S. under an Emergency Use Authorization. Common adverse reactions include headache, nausea, muscle pain, joint pain, injection site tenderness, fatigue, and malaise. The vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years and older.
Novavax (Nasdaq: NVAX) has announced that Dr. Ruxandra Draghia-Akli will join the company in November 2024 as Executive Vice President and Head of Research & Development. Dr. Draghia-Akli brings over 20 years of experience in vaccines and public health, with expertise in clinical, corporate, and policy work. Her appointment comes as Novavax transitions to an R&D-focused organization with an expanded pipeline.
Dr. Draghia-Akli's previous roles include Global Head of Global Public Health R&D at Johnson & Johnson and Vice President of Global Vaccines at Merck. She has also worked with the European Commission on research and innovation issues. Her experience in both large pharmaceutical companies and smaller biotechs is expected to be valuable in strategically evaluating Novavax's portfolio and the potential of its scientific technology, including the Matrix-M™ adjuvant.
Novavax (Nasdaq: NVAX) announced the availability of its updated 2024-2025 Formula COVID-19 Vaccine at major U.S. pharmacies.
This protein-based vaccine, approved under Emergency Use Authorization (EUA) by the FDA on August 30, 2024, targets the JN.1 strain and shows cross-reactivity with other strains.
It's formulated for individuals aged 12 and older and is available in pre-filled syringes at CVS, Rite Aid, Walgreens, Costco, Sam's Club, and other retailers.
Novavax has expanded its distribution network, more than doubling the locations from last year. Important safety information includes risks of myocarditis and pericarditis, and common adverse reactions like injection site pain and fatigue.
Novavax (Nasdaq: NVAX), a global protein-based vaccine company, has announced its participation in two upcoming investor conferences in September 2024. The company will be present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9, featuring a fireside chat and investor meetings. Additionally, Novavax will attend the Baird 2024 Global Healthcare Conference on September 10, delivering a presentation and holding investor meetings.
Key participants from Novavax include Jim Kelly, Executive Vice President, CFO and Treasurer, and Dr. Robert Walker, Senior Vice President, CMO and Interim Head of R&D. Both events will take place in New York City. Replays of the fireside chat and presentation will be available on the company's website for 30 days following the conferences.
Novavax has received Emergency Use Authorization (EUA) from the FDA for its 2024-2025 Formula COVID-19 Vaccine (NVX-CoV2705) for individuals aged 12 and older. The vaccine is included in the CDC's recommendations and will be available in pre-filled syringes at thousands of locations across the U.S. Novavax's vaccine is the only protein-based option available in the U.S. for COVID-19 prevention.
The updated vaccine targets the JN.1 variant, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses. The EUA was based on non-clinical data demonstrating protection against JN.1 and its lineage viruses. Common adverse reactions include headache, nausea, muscle pain, and injection site tenderness.
Novavax (NVAX) reported Q2 2024 financial results with total revenue of $415 million and ended the quarter with $1.1 billion in cash. Key highlights include:
1. Filed for authorization of updated 2024-2025 COVID-19 vaccine with FDA and EMA
2. Received $570 million from Sanofi partnership (upfront payment and equity investment)
3. Planning Phase 3 trials for COVID-19-Influenza Combination and stand-alone influenza vaccines in Q4 2024
4. Achieved 34% reduction in R&D and SG&A expenses compared to Q2 2023
5. Reported net income of $162 million for Q2 2024
Novavax updated its 2024 guidance, expecting total revenue of $700-$800 million and combined R&D and SG&A expenses of $700-$750 million.
Novavax (Nasdaq: NVAX) has announced it will report its second quarter 2024 financial results and operational highlights on August 8, 2024 at 8:30 a.m. Eastern Time. The company, which focuses on advancing protein-based vaccines with its Matrix-M™ adjuvant, will host a conference call and webcast for this purpose. Participants can join via phone or webcast, with registration available through a provided URL. The call will be accessible domestically at (800) 836-8184 and internationally at (+1) (646) 357-8785. A replay will be available from 11:30 a.m. ET on August 8 until August 15, 2024, with the webcast replay extending to September 8, 2024.
Novavax (Nasdaq: NVAX) announced it has submitted a type II variation application to the European Medicines Agency (EMA) for its updated JN.1 COVID-19 vaccine (NVX-CoV2705), intended for individuals aged 12 and older. The vaccine is designed to address current circulating strains, including KP.2 and KP.3. This submission follows EMA and WHO guidance to target the JN.1 lineage this fall.
Nonclinical data indicate the vaccine induces broad neutralization responses to various JN.1 lineage viruses, including mutations F456L and R346T, and variants like
Novavax has submitted an amendment for Emergency Use Authorization to the U.S. FDA for its updated JN.1 COVID-19 vaccine, NVX-CoV2705, for ages 12 and older. This protein-based vaccine targets the JN.1 lineage, effective against strains like KP.2 and KP.3. The submission aligns with global recommendations from the FDA, EMA, and WHO. Novavax plans to distribute pre-filled syringes in the U.S. by mid-August, pending authorization and CDC recommendation. Preclinical data indicates broad neutralization and robust immune responses. The vaccine uses Novavax's recombinant nanoparticle technology and Matrix-M adjuvant.
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