Novavax Inc - NVAX STOCK NEWS

Novavax, Inc. (Nasdaq: NVAX) will participate in a fireside chat during the SVB Securities Virtual Vaccine Forum on August 18, 2022, from 11:00 to 11:50 a.m. EDT. The discussion will focus on NVX-CoV2373, Novavax's recombinant nanoparticle protein-based COVID-19 vaccine candidate. Key participants include Filip Dubovsky, M.D., and John J. Trizzino. Novavax's COVID-19 vaccine has received multiple global authorizations and is under review for additional populations. The company is also evaluating a combination vaccine candidate and new Omicron strain-based vaccines.

Novavax (NVAX) has received FDA Emergency Use Authorization for NVX-CoV2373, becoming the first protein-based COVID-19 vaccine authorized for adults in the U.S. The company reported a total revenue of $186 million in Q2 2022, a decline from $298 million the previous year, with adjusted revenue guidance set between $2 billion and $2.3 billion for the year. Despite delivering over 73 million doses globally, Novavax faced a net loss of $510 million. The company continues to progress its variant program, with further clinical data expected.

Novavax announced the initiation of its Phase 2b/3 Hummingbird global clinical trial for the COVID-19 vaccine (NVX-CoV2373) targeting children aged six months to 11 years. The trial will evaluate safety, immunogenicity, and efficacy of two doses, followed by a booster. Enrollment will include 3,600 participants from several countries, with initial results expected in Q1 2023. CEO Stanley C. Erck expressed optimism about expanding vaccine access to all age groups in the ongoing pandemic.

Novavax, Inc. (Nasdaq: NVAX) will report its Q2 2022 financial results and operational highlights on August 8, 2022, after U.S. market close. A conference call is scheduled for 4:30 p.m. EDT, and participants are encouraged to join 10 minutes early. The event will be available for replay starting at 7:30 p.m. EDT on the same day until August 15, 2022. Novavax emphasizes its commitment to developing vaccines for serious infectious diseases, including its COVID-19 vaccine, NVX-CoV2373, now authorized globally.

Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 vaccine, Nuvaxovid™, received expanded approval from Japan's Ministry of Health for use in adolescents aged 12 to 17. This approval is based on data from a pivotal Phase 3 trial demonstrating 80% clinical efficacy among 2,247 participants, particularly during the Delta variant surge. Novavax has partnered with Takeda for manufacturing and distribution in Japan. Nuvaxovid has also been authorized in multiple countries, including the European Union and India, and is under review in additional markets.

Novavax (Nasdaq: NVAX) announced that the Australian Therapeutic Goods Agency has granted provisional registration for its COVID-19 vaccine, Nuvaxovid™, for adolescents aged 12 to 17. This decision aims to address rising COVID-19 cases in Australia, especially as schools reopen. Based on the pediatric expansion of the PREVENT-19 clinical trial, Nuvaxovid demonstrated an overall efficacy of 80%, with a favorable safety profile. The vaccine is already conditionally authorized in the European Union and received emergency use authorization in India. This marks an important step in expanding vaccination access.

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the use of the Novavax COVID-19 Vaccine, Adjuvanted, as a two-dose primary series for individuals aged 18 and older. This follows the Emergency Use Authorization (EUA) granted by the U.S. FDA. Novavax expects to begin shipping doses to designated distribution centers soon. The vaccine is the first FDA-authorized protein-based COVID-19 vaccine in the U.S., with a reported efficacy of 90.4% based on the Phase 3 PREVENT-19 trial involving nearly 30,000 participants.

Novavax, Inc. (Nasdaq: NVAX) has expanded its collaboration with SK bioscience to manufacture a version of its COVID-19 vaccine (NVX-CoV2373) targeting the Omicron variant. This includes a technology transfer for creating COVID-19 variant antigens and the manufacture of the vaccine in prefilled syringes, expected to begin in 2023. Non-clinical data shows the vaccine elicits broad immune responses against variants, including Omicron BA.5. Additionally, Novavax is evaluating the efficacy of their vaccine in Phase 3 trials, with previous trials showing over 90% efficacy. Funding includes up to $1.75 billion from the U.S. government.

On July 13, 2022, Novavax announced that its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), received Emergency Use Authorization (EUA) from the U.S. FDA, marking it as the first protein-based COVID-19 vaccine authorized in the U.S. The two-dose series will be available for individuals aged 18 and over upon CDC recommendation. The vaccine demonstrated 90.4% efficacy in clinical trials involving 30,000 participants. Novavax will supply an initial 3.2 million doses, which will be provided for free through federal health agencies.