Novavax Inc - NVAX STOCK NEWS

Novavax (Nasdaq: NVAX) will participate in Cowen's 42nd Annual Healthcare Conference on March 8, 2022, from 9:50 – 10:20 a.m. EST. The session will focus on their recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373. Key company executives, including Filip Dubovsky and John J. Trizzino, will present. A recorded session will be available on the company's website for 90 days post-conference. Novavax is also developing a COVID-influenza combination vaccine currently in clinical trials.

Novavax has received multiple global regulatory authorizations for its COVID-19 vaccine NVX-CoV2373, including from the EU, WHO, and Australia. The company reported $1.1 billion in revenue for 2021, a significant increase from $476 million in 2020, with projected 2022 revenues between $4 billion and $5 billion. The vaccine demonstrated 82.5% efficacy and broad cross-reactivity against variants. While research and development costs surged to $2.5 billion, the company showcased robust cash reserves of $1.5 billion, marking a positive financial position.

Novavax, Inc. (Nasdaq: NVAX) reported findings from an extended analysis of its Phase 3 clinical trial for the protein-based COVID-19 vaccine NVX-CoV2373 in the UK. The data indicates a sustained vaccine efficacy of 82.5% over a six-month period, demonstrating significant protection against both symptomatic and asymptomatic COVID-19. Notably, efficacy against severe disease was reported at 100%. The vaccine maintains a reassuring safety profile, with adverse events reported equally among vaccine and placebo groups. These results support ongoing regulatory submissions and future vaccine distribution efforts.

Novavax, Inc. (Nasdaq: NVAX) will report its fourth quarter and full year 2021 financial results on February 28, 2022, after U.S. markets close. The conference call is scheduled for 4:30 p.m. EST, with a replay available from 7:30 p.m. EST until March 7, 2022. Novavax is focused on next-generation vaccines, including its COVID-19 vaccine, which has received conditional authorization globally. The company is also developing a COVID-seasonal influenza combination vaccine, currently in a Phase 1/2 clinical trial.

Novavax, Inc. announced that Health Canada has authorized the use of its COVID-19 vaccine, Nuvaxovid™, for individuals aged 18 and older. This protein-based vaccine is the first of its kind approved in Canada. The authorization follows extensive preclinical and clinical trial data, including two pivotal Phase 3 trials demonstrating efficacy and a favorable safety profile. Novavax also has a supply agreement for 52 million doses with the Canadian government. The company plans to start manufacturing the vaccine at the National Research Council's facility in Montreal later this year.

Novavax, Inc. (Nasdaq: NVAX) announced on February 14, 2022, that the Singapore Health Sciences Authority (HSA) granted interim authorization for its Nuvaxovid™ COVID-19 vaccine. This vaccine is the first protein-based option authorized in Singapore for individuals 18 and older. The authorization follows the submission of data from pivotal Phase 3 trials, demonstrating efficacy and a favorable safety profile. Initial doses are projected to arrive in Singapore by the end of March. While Nuvaxovid is authorized in Singapore, it has yet to receive FDA approval for use in the U.S.

Novavax, Inc. (Nasdaq: NVAX) announced the submission for conditional marketing authorization (CMA) of its COVID-19 vaccine candidate NVX-CoV2373 to Swissmedic on February 14, 2022. The vaccine, utilizing a recombinant nanoparticle protein-based approach with Matrix-M™ adjuvant, has demonstrated efficacy in pivotal Phase 3 trials comprising approximately 45,000 participants in the U.S., Mexico, and U.K. Novavax aims to address vaccination gaps in Switzerland. The vaccine has already received conditional authorizations from multiple global regulatory agencies, including the European Commission and WHO.

Novavax, a biotechnology company, will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022. The discussion will focus on NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate. The chat is scheduled from 11:20 to 11:50 a.m. EST, moderated by David Risinger, featuring executives Filip Dubovsky and John J. Trizzino. A recorded replay will be available on the company’s website for 90 days.

Novavax (NVAX) announced that its COVID-19 vaccine, NVX-CoV2373, met primary effectiveness endpoints in the PREVENT-19 trial's pediatric expansion for adolescents aged 12-17. The trial, involving 2,247 participants, demonstrated 82% clinical efficacy against the Delta variant and showed robust immune responses, significantly higher than those in adults. The vaccine displayed a reassuring safety profile with no safety signals identified. Novavax plans to submit pediatric data for regulatory filings in Q1 2022, aiming for broader vaccine access in over 170 countries.