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 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.
Novavax (Nasdaq: NVAX) announced its participation in the 2024 Jefferies Global Healthcare Conference.
The event includes a Fireside Chat on June 6, 2024, from 12:30 – 12:55 p.m. ET in New York, NY, moderated by Roger Song, MD, CFA, an Equity Research Analyst in Biotechnology. John C. Jacobs, Novavax's President and CEO, will represent the company.
Additionally, Novavax will hold investor meetings on the same day. A replay of the fireside session will be available on the company's website for 30 days post-conference.
Novavax (Nasdaq: NVAX) announced its participation in the BofA Securities 2024 Health Care Conference. The event will feature a fireside chat on May 15, 2024, from 3:00 to 3:30 p.m. PDT at the Encore Hotel in Las Vegas, moderated by Alec Stranahan, PhD. John C. Jacobs, President and CEO of Novavax, will represent the company. The session aims to discuss Novavax's progress with its protein-based vaccines and Matrix-M™ adjuvant. A recording of the session will be available for 30 days on the company's website.
Novavax reported its financial results and operational highlights for Q1 2024, including a co-exclusive licensing agreement with Sanofi for COVID-19 vaccines, a Phase 3 trial for a combination flu-COVID-19 vaccine, and a standalone influenza vaccine. The agreement holds potential multi-billion dollar revenue opportunities for Novavax, including upfront payments, equity investments, milestones, and royalties. Novavax also reduced liabilities by $831 million and achieved $94 million in revenue for Q1 2024. The company's financial position improved, with reduced losses and cash reserves of $496 million as of March 31, 2023.
Novavax and Sanofi have entered into a co-exclusive licensing agreement to co-commercialize a protein-based COVID-19 vaccine and develop novel COVID-19-Influenza combination vaccines. The agreement provides broader access to the vaccine from 2025 onwards and includes a cash and equity investment of approximately $1.2 billion for Novavax. This collaboration aims to accelerate the development of a combination product based on authorized vaccines for enhanced convenience and protection.
Novavax, Inc. will host a conference call to discuss its first quarter 2024 financial results and operational highlights on May 10, 2024. The company is a global leader in protein-based vaccines with its Matrix-M™ adjuvant. Details of the event and how to join are provided in the press release.
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