Novavax Inc Stock Price, News & Analysis

Novavax, Inc. (Nasdaq: NVAX) announced its participation in the 2020 World Vaccine Congress, presenting updates on its vaccine candidates NVX-CoV2373 (COVID-19), NanoFlu™, and ResVax™. Key presentations include NVX-CoV2373's recombinant nanoparticle technology on September 28 and updates on maternal RSV and influenza vaccine programs on October 1. The company aims to address emerging infectious diseases and has secured significant funding, including $2 billion for its coronavirus vaccine initiatives. Experts from Novavax will collaborate with global leaders in public health during the congress.

On September 24, 2020, Maryland Governor Larry Hogan and BIO President Dr. Michelle McMurry-Heath highlighted Novavax's efforts in vaccine development against COVID-19 during an event at the company’s Gaithersburg facility. Novavax is preparing to initiate three Phase 3 trials for its vaccine candidate, NVX-CoV2373, with global trials in the UK, US, and India. The company's commitment reflects its responsibility to ensure widespread protection against the virus, underscoring the vital role of the biotechnology sector in combating health crises.

Novavax (Nasdaq: NVAX) has initiated its first Phase 3 study of NVX-CoV2373, a COVID-19 vaccine candidate, in the UK, aiming to enroll up to 10,000 participants aged 18-84. This trial explores the vaccine's efficacy, safety, and immunogenicity, with results expected to support regulatory submissions. The vaccine utilizes Novavax's recombinant protein nanoparticle technology and can be stored at standard refrigeration temperatures. Manufacturing capacity is set to reach 2 billion doses annually by mid-2021.

Novavax (Nasdaq: NVAX) has announced a significant agreement with Serum Institute of India to manufacture approximately 1 billion doses of its COVID-19 vaccine candidate, NVX-CoV2373, in 2021. This expands Novavax's global manufacturing capacity to over 2 billion doses annually when fully operational. The agreement establishes a robust supply chain, with production facilities across multiple continents, and supports Novavax's commitment to equitable vaccine distribution. The vaccine is currently in Phase 2 clinical trials, with Phase 3 trials anticipated soon.

Novavax (Nasdaq: NVAX) announced its participation in five investor conferences, highlighting its COVID-19 vaccine candidate NVX-CoV2373. Key events include:

• Citi 15th Annual BioPharma Virtual Conference on September 10, 2020
• H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, 9:30 a.m. ET
• Cantor Virtual Global Healthcare Conference on September 15, 2020, 11:20 a.m. ET
• Morgan Stanley Virtual 18th Annual Global Healthcare Conference on September 16, 2020, 12:30 p.m. ET
• Leerink CyberRx Series: Vaccine Forum on September 23, 2020, 9:00 a.m. ET

Replays will be available on Novavax's website.

Novavax (Nasdaq: NVAX) announced the publication of Phase 1 data for its COVID-19 vaccine candidate, NVX-CoV2373, in The New England Journal of Medicine. The results indicate a strong safety profile and superior antibody responses compared to human convalescent sera. Following positive Phase 1 results, multiple Phase 2 trials commenced in the US, Australia, and South Africa to further evaluate efficacy. The funding for the trial includes support from the Coalition for Epidemic Preparedness Innovations (CEPI). NVX-CoV2373 showcases a favorable product profile, with stability for easy storage.

Novavax (NVAX) has reached an agreement with the Canadian government to supply up to 76 million doses of its COVID-19 vaccine, NVX-CoV2373, set to start in the second quarter of 2021. The deal aims to ensure broad access to the vaccine, which is currently in multiple Phase 2 clinical trials, including a Phase 2b trial in South Africa. NVX-CoV2373 utilizes Novavax's proprietary Matrix-M™ adjuvant to enhance immune responses. The agreement will finalize subject to Health Canada's licensure of the vaccine.

Novavax (Nasdaq: NVAX) announced the enrollment of first volunteers in the Phase 2 clinical trial of its COVID-19 vaccine candidate, NVX-CoV2373. This trial aims to assess immunogenicity and safety, expanding the age range to include participants aged 60-84 years, who constitute about 50% of the trial population. The trial will enroll up to 1,500 volunteers across the U.S. and Australia, with preliminary efficacy evaluations as a secondary objective. Interim data is expected in Q4 2020, following encouraging Phase 1 results that showed robust antibody responses.

Novavax, Inc. (NASDAQ: NVAX) has announced the initiation of a Phase 2b clinical trial in South Africa for its COVID-19 vaccine candidate NVX-CoV2373. The trial, led by Professor Shabir Madhi, aims to assess the vaccine's efficacy with a $15 million grant from the Bill & Melinda Gates Foundation. Approximately 2,665 healthy adults and 240 medically stable, HIV-positive adults will participate. The trial infrastructure and seasonal COVID-19 transmission could allow for rapid evaluation of efficacy. If successful, the vaccine may be supplied to South Africa through Novavax's collaboration with the Serum Institute of India.