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 (NVAX) is a clinical-stage biotechnology company pioneering vaccine development through recombinant nanoparticle technology and its proprietary Matrix-M adjuvant. This dedicated news hub provides investors and industry observers with timely updates on corporate developments, clinical trial progress, and regulatory milestones.
Our curated collection of Novavax news ensures access to official press releases, financial disclosures, and strategic partnership announcements. Users will find updates spanning vaccine candidate advancements, manufacturing expansions, and peer-reviewed research findings. Key content areas include quarterly earnings reports, FDA regulatory submissions, and global health collaborations.
Bookmark this page for streamlined tracking of Novavax's progress in addressing infectious diseases like COVID-19, influenza, and RSV. The resource is regularly updated to serve as your primary source for verified information about NVAX's scientific innovations and market positioning.
Novavax announced that the FDA has removed the clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the company to begin enrolling participants for the planned Phase 3 trial after determining that Novavax satisfactorily addressed all clinical hold issues. The hold, announced on October 16, 2024, was due to a serious adverse event reported in a participant who received the investigational CIC vaccine in a Phase 2 trial completed in 2023. The adverse event, initially reported as motor neuropathy, was later reclassified as amyotrophic lateral sclerosis, which is not associated with vaccination. Novavax plans to start the Phase 3 trial as soon as possible.
Novavax (NVAX) has scheduled its third quarter 2024 financial results and operational highlights conference call for November 12, 2024, at 8:30 a.m. ET. The company will host both a conference call and webcast, with replay options available until November 19, 2024, for the call and December 12, 2024, for the webcast. Participants can join through automated callback registration or direct operator assistance, and are advised to connect 10 minutes before the scheduled start.
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.
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