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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) 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.
Novavax (Nasdaq: NVAX) has announced that CEO Stanley C. Erck will take part in a panel discussion at the BIO International Convention 2021 on June 14. The event, hosted by the Biotechnology Innovation Organization, is scheduled for June 10-11 and June 14-18. The panel will focus on global pandemic preparedness, featuring discussions about Novavax's COVID-19 vaccine candidate, NVX-CoV2373. This protein-based vaccine is designed to combat SARS-CoV-2 and is currently under evaluation in multiple clinical trials.
Novavax (Nasdaq: NVAX), a biotechnology company specializing in vaccines, announced participation in the Jefferies Virtual Healthcare Conference on June 1, 2021, at 1:30 p.m. ET. The event will feature discussions about its COVID-19 vaccine candidate, NVX-CoV2373. Key participants include Gregory M. Glenn, M.D., and John Trizzino. A replay of the session will be available on the company’s website for 90 days. Novavax aims to combat serious infectious diseases through innovative vaccines and is advancing its COVID-19 and NanoFlu vaccine candidates in clinical trials.
Novavax, Inc. (Nasdaq: NVAX) announced that Gregory M. Glenn, M.D., will present on NVX-CoV2373, its COVID-19 vaccine candidate, at the 2021 International Society for Vaccines Virtual Congress on May 25, 2021. The presentation will cover safety, efficacy, and immunogenicity data. A recent analysis from Phase 3 trials in the U.K. shows approximately 90% efficacy against COVID-19, with impressive results against variants. NVX-CoV2373 utilizes Novavax's proprietary recombinant nanoparticle technology and Matrix-M™ adjuvant to enhance immune response.
Novavax, Inc. (Nasdaq: NVAX) has signed a non-binding memorandum of understanding (MoU) with Korea's Ministry of Health and Welfare and SK bioscience to enhance cooperation in developing and manufacturing vaccines, including NVX-CoV2373, its COVID-19 vaccine candidate. This partnership underscores Novavax's commitment to ensuring global vaccine access. The MoU builds on existing collaboration and aims to explore new vaccine products for COVID-19 variants and an influenza-COVID-19 combination. SK bioscience has initiated the regulatory submission process for NVX-CoV2373 in South Korea.
On May 21, 2021, Novavax (Nasdaq: NVAX) was awarded 'Life Sciences Company of the Year' by the Maryland Tech Council, with CEO Stanley C. Erck receiving 'Life Sciences Chief Executive Officer of the Year.' The awards recognize Novavax's role in accelerating equitable access to COVID-19 vaccines. NVX-CoV2373, their protein-based vaccine candidate, has shown efficacy in trials, including 96.4% against the original strain and 86.3% against the B.1.1.7 variant. The U.S. and Mexico PREVENT-19 trial began in December 2020, further solidifying their commitment to global health.
Novavax, Inc. (NASDAQ: NVAX) reported significant progress in Q1 2021, achieving 96.4% efficacy against the original COVID-19 strain and 86.3% against the B.1.1.7 variant in a Phase 3 UK trial. The company reported revenues of $447 million compared to $3 million in Q1 2020, but incurred a net loss of $223 million per share, up from $26 million a year earlier. Novavax also bolstered its manufacturing capacity with plans to produce 100 million doses per month by Q3 2021 and secured several global agreements for vaccine distribution.
Novavax (Nasdaq: NVAX) announced promising results from a preclinical study of its combination vaccine, NanoFlu/NVX-CoV2373, which targets both influenza and COVID-19. The vaccine demonstrated strong immune responses against influenza A, B, and SARS-CoV-2, with clinical trials expected to start by year-end. The study showed that the combination vaccine elicited comparable antibody responses to individual vaccines and effectively protected hamsters from SARS-CoV-2 infection. Novavax aims to address public health needs with this novel vaccine strategy.