Novavax Inc - NVAX STOCK NEWS

Novavax (NVAX) reported a significant net loss of $352 million for Q2 2021, translating to $4.75 per share, compared to a loss of $18 million in Q2 2020. Revenue surged to $298 million from $36 million, driven by development activities for NVX-CoV2373. R&D expenses skyrocketed to $571 million, up from $35 million year-over-year. The company holds $2.1 billion in cash as of June 30, 2021, facilitating ongoing vaccine development and regulatory submissions globally. Key vaccine advancements include 90.4% efficacy in the Phase 3 trial and plans to file for emergency authorizations in several markets.

Novavax (Nasdaq: NVAX) announced promising preliminary data from a Phase 2 study revealing that a single booster dose of its NVX-CoV2373 COVID-19 vaccine, administered six months after initial vaccination, resulted in a 4.6-fold increase in functional antibody titers. Additionally, the booster elicited a more than six-fold increase in antibodies against the Delta variant. The study underscored a favorable safety profile, with side effects primarily mild and transient. The full data will be submitted for peer review.

Novavax, in partnership with the Serum Institute of India, has filed for emergency use authorization for its recombinant nanoparticle COVID-19 vaccine in India, Indonesia, and the Philippines. This is the first protein-based COVID-19 vaccine submission to any regulatory body. A submission for World Health Organization Emergency Use Listing is expected in August 2021. The vaccine, NVX-CoV2373, shows high efficacy rates and is designed to be stable in standard cold chain conditions. Novavax and SII are committed to providing over 1.1 billion doses to the COVAX Facility.

Novavax (Nasdaq: NVAX) announced a significant agreement with the European Commission for up to 200 million doses of its COVID-19 vaccine, NVX-CoV2373, including an initial purchase of 100 million doses. Deliveries are set to commence post-approval from the European Medicines Agency, expected in Q3 2021. Clinical trials showed NVX-CoV2373's efficacy at 90.4% against overall infection and 100% against severe disease. This partnership aims to bolster vaccine options for Europe and globally amid the ongoing pandemic.

Novavax, Inc. (Nasdaq: NVAX) will announce its second quarter 2021 financial results and operational highlights on August 5, 2021, at 4:30 p.m. ET. The announcement will be followed by a conference call, accessible at www.novavax.com/events. Notably, Novavax is conducting late-stage clinical trials for its COVID-19 vaccine, NVX-CoV2373, and has achieved positive results with its NanoFlu™ vaccine for influenza, which met all primary objectives in its Phase 3 trial.

Novavax, Inc. (Nasdaq: NVAX) released the final analysis of its pivotal Phase 3 clinical trial for the COVID-19 vaccine NVX-CoV2373, published in the New England Journal of Medicine. The trial demonstrated an overall efficacy of 89.7% against all strains and 96.4% against non-B.1.1.7 variants. Conducted in the UK with over 15,000 participants, the study confirmed the vaccine's strong safety and efficacy profile, highlighting its potential in combating COVID-19. The results align closely with previous trial data, reinforcing confidence in NVX-CoV2373's role in the pandemic response.

Novavax, Inc. (Nasdaq: NVAX) announced participation in the 2nd Annual CybeRx Series: Vaccine Forum on June 22, 2021. The fireside chat will feature discussions around NVX-CoV2373, Novavax's recombinant nanoparticle protein-based COVID-19 vaccine. The event will be moderated by Geoffrey Porges, with Novavax leaders Gregory M. Glenn and John J. Trizzino participating. This forum highlights Novavax's innovative approach to vaccine development, particularly in combating serious infectious diseases.

Novavax, a biotechnology company, announced that Gregory M. Glenn, M.D., its President of Research and Development, will participate in a session at the National Vaccine Advisory Committee meeting on June 17, 2021. The discussion will focus on Novavax' COVID-19 vaccine candidate, NVX-CoV2373. The session is scheduled from 3:15 p.m. to 4:15 p.m. ET, titled Experiences in the Field: COVID-19 Vaccine Authorization and Beyond. Novavax is advancing its vaccine to combat SARS-CoV-2, aiming to enhance global health through innovative vaccines.

Novavax (Nasdaq: NVAX) announced promising results from its first co-administration study of its COVID-19 vaccine candidate, NVX-CoV2373, alongside an influenza vaccine. Conducted in the UK with 431 volunteers, the study showed vaccine efficacy rates of 87.5% for the co-administered group and 89.8% for the main study. The findings suggest that simultaneous vaccination could enhance public health efforts by reducing healthcare visits. The vaccine demonstrated a favorable safety profile, with mild reactogenicity and preserved immunogenicity for the influenza vaccine.