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 (NVAX) has granted inducement awards to its newly appointed Executive Vice President and Head of Research & Development, Dr. Ruxandra Draghia-Akli. The awards include a non-qualified stock option to purchase 64,150 shares at $9.01 per share and restricted stock units for 42,770 shares. The stock option will vest 25% after one year, with remaining shares vesting monthly over 36 months. The restricted stock units will vest in three equal annual installments. Both awards are subject to continued employment and were granted under the Novavax 2023 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
Novavax (NVAX) has announced its participation in the upcoming Jefferies London Healthcare Conference. The company will engage in a fireside chat on November 20, 2024, from 11:00 to 11:25 AM GMT in London. The session will be moderated by Roger Song, MD, CFA, with participation from President and CEO John C. Jacobs and other management team members.
The company will also conduct investor meetings on the same day. A replay of the fireside chat will be accessible for 30 days on Novavax's investor relations website at ir.novavax.com.
Novavax (NVAX) reported Q3 2024 financial results with total revenue of $85 million, down from $187 million in Q3 2023. The company ended the quarter with $1 billion in cash and receivables. Key developments include FDA's removal of clinical hold on COVID-19-Influenza Combination vaccine candidates and authorization for updated 2024-2025 COVID-19 vaccine. The company updated its 2024 guidance, lowering total revenue expectations to $650-700 million from previous $700-800 million. Q3 net loss was $121 million, improving from $131 million loss in Q3 2023. Cost reduction efforts showed a 26% decrease in R&D and SG&A expenses compared to previous year.
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.
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