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 biotechnology company focused on vaccines, using a platform that combines protein-based nanoparticles with its proprietary Matrix-M® adjuvant. News about Novavax often centers on its COVID-19 vaccine Nuvaxovid™/Nuvaxovid®, its broader infectious disease pipeline, and the progress of key partnerships and collaborations.
Recent announcements highlight Novavax’s collaboration and license agreement with Sanofi, under which Sanofi has taken on lead commercial and regulatory responsibilities for Nuvaxovid in selected markets. News items cover marketing authorization transfers in the European Union and United States, milestone payments to Novavax, and Sanofi’s clinical data on combination vaccine candidates that incorporate Nuvaxovid and Matrix-M. Updates also describe regulatory approvals in markets such as Japan through partner Takeda, triggering additional milestone payments and royalty opportunities.
Investors following NVAX news will see regular coverage of quarterly financial results, revenue composition from product sales, supply sales and licensing and royalty streams, as well as information on Novavax’s site consolidation and cost footprint in Maryland. The company’s communications also describe early-stage research on vaccine candidates for shingles, Clostridioides difficile colitis and respiratory syncytial virus combinations, and the use of Matrix-M in the R21/Matrix-M malaria vaccine developed with Serum Institute of India and Oxford University.
This page aggregates press releases, conference participation announcements, regulatory updates and other material events related to Novavax. Readers can use it to monitor developments in the company’s vaccine programs, partnership milestones, capital structure transactions and strategic transformation as disclosed in public statements.
Novavax, Inc. (NASDAQ: NVAX) announced the availability of one million doses of its COVID-19 vaccine, Nuvaxovid™ (NVX-CoV2373), in the United Kingdom. This protein-based vaccine is the first of its kind authorized by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA). Nuvaxovid is essential for addressing COVID-19 and flu co-infections, which significantly increase mortality risk. The vaccine's complete clinical trials have shown efficacy rates of 90.4% in adults and 80% in adolescents. Future plans include seeking further authorization for its use as a booster in adults.
Novavax, Inc. (Nasdaq: NVAX) announced that the Taiwan Food and Drug Administration (TFDA) has granted expanded emergency use authorization (EUA) for its COVID-19 vaccine, Nuvaxovid™, for adolescents aged 12 to 17. This decision follows positive data from the Phase 3 PREVENT-19 clinical trial, which demonstrated 78.29% efficacy against COVID-19 during the Delta variant's predominance. Adverse reactions were generally mild to moderate and comparable to those observed in adults. Nuvaxovid has already been authorized in over 10 markets for this age group, enhancing vaccine access as COVID-19 cases are anticipated to rise in colder months.
The Israeli Advisory Committee on Epidemics has recommended the approval of Nuvaxovid™, Novavax's COVID-19 vaccine, for individuals aged 12 and older as a primary series and a heterologous booster. The Israel Ministry of Health has granted an import and use permit, allowing access to the vaccine. Nuvaxovid is already authorized for adults in over 40 markets globally, including the U.S. and WHO. The vaccine utilizes a protein-based approach and is part of ongoing Phase 3 trials, showing efficacy rates of up to 90.4% in adult populations and 80% in adolescents.
Novavax, Inc. (Nasdaq: NVAX) announced that its protein-based COVID-19 vaccine, NVX-CoV2373, has received full product registration with conditions from the South African Health Products Regulatory Authority. This two-dose vaccine is authorized for use in adults aged 18 and older and is marketed as Covovax™. The registration is based on Phase 3 clinical trials, which demonstrated overall efficacy rates of 90.4% and 89.7% in separate studies. The vaccine has also received approvals from over 43 countries, including the U.S. and WHO.
Novavax, Inc. (Nasdaq: NVAX) announced the European Commission's approval of its Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine as a booster for adults aged 18 and older. This expanded conditional marketing authorization allows the vaccine to be administered regardless of prior vaccination. The approval follows favorable results from multiple Phase 2 trials demonstrating increased immune responses and overall safety. Nuvaxovid is already approved in several other regions, including Japan and Australia, and targets variants, showing efficacy against Omicron strains.
On September 7, 2022, Novavax (Nasdaq: NVAX) announced its participation in two investor conferences. The discussions will focus on its COVID-19 vaccine, NVX-CoV2373. The first conference, H.C. Wainwright 24th Annual Global Investment Conference, is scheduled for September 12, 2022, from 4:00 to 4:30 p.m. EDT at Lotte New York Palace Hotel. The second, Baird 2022 Global Healthcare Conference, will take place on September 13, 2022, from 8:30 to 9:00 a.m. EDT at Intercontinental New York Barclay Hotel. Recordings of the sessions will be available on Novavax's website for 90 days.
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Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 vaccine, Nuvaxovid™, has been recommended for expanded conditional marketing authorization (CMA) in the EU as a homologous and heterologous booster for adults 18 and older. This recommendation by the CHMP is based on data from Phase 2 trials conducted in Australia, South Africa, and the UK. Nuvaxovid has already been approved in Japan, Australia, and New Zealand. As the pandemic evolves, Novavax aims to enhance global access to diversified vaccine options.
Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 vaccine, Nuvaxovid™, received expanded conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency for use in adolescents aged 12 to 17. This marks the first protein-based COVID-19 vaccine available for this age group in the UK. The authorization is based on data from the pediatric expansion of the Phase 3 PREVENT-19 trial, where Nuvaxovid demonstrated 80% clinical efficacy during the Delta variant surge. The next step involves a policy recommendation from the UK Joint Committee on Vaccination and Immunisation.
Novavax, Inc. (Nasdaq: NVAX) announced the FDA has granted expanded emergency use authorization for its COVID-19 Vaccine, Adjuvanted for adolescents aged 12-17. This marks it as the first protein-based COVID-19 vaccine authorized in the U.S. A clinical trial involving 2,247 participants demonstrated an overall efficacy of 78.29% against the Delta variant. Vaccination immunizations for adolescents can start following CDC recommendations. Safety data indicates a well-tolerated profile with mild side effects. The vaccine remains authorized under EUA and is designed to enhance vaccination rates as COVID-19 cases surge.
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