Novavax Inc - NVAX STOCK NEWS

Novavax, Inc. (Nasdaq: NVAX) announced a proposed offering of $125 million in convertible senior notes due 2027. These notes will be sold to qualified institutional buyers under Rule 144A. The company may also offer up to $125 million in common stock, with an additional $18.75 million option for both offerings. Proceeds will support general corporate purposes, including the launch of Nuvaxovid and repay existing convertible notes. The offering is not contingent on the other, and the financial terms will be set at pricing.

On December 7, 2022, Novavax, Inc. (Nasdaq: NVAX) announced that Health Canada has approved the Nuvaxovid COVID-19 Vaccine for use as a primary series for adolescents aged 12 to 17. This approval is based on data from the Phase 3 PREVENT-19 trial, demonstrating a clinical protective efficacy of 79.5%, particularly against the Delta variant. Nuvaxovid is already authorized in over 10 markets globally, including the U.S. and European Union. The vaccine will be manufactured in Montreal, with engineering runs completed and production of qualification batches expected to start in early 2023.

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company focused on developing vaccines for infectious diseases, announced its participation in the BofA Securities 2022 Virtual Biotech SMID Cap Conference on December 7, 2022. The fireside chat will feature discussions on its recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, from 9:10 – 9:35 a.m. EST. Novavax executives, including Chief Medical Officer Filip Dubovsky, will participate. A recording will be available on the company’s website for 90 days post-conference.

Novavax, Inc. (Nasdaq: NVAX) announced an updated Emergency Use Listing (EUL) from the WHO for its Nuvaxovid™ COVID-19 vaccine. This listing allows the vaccine to be used as a primary series for adolescents aged 12-17 and as a booster for adults 18 and older. Clinical data demonstrated Nuvaxovid's efficacy of 80% in adolescents during the Delta variant surge, with a low incidence of adverse reactions. The vaccine is authorized in over 10 markets, including the U.S. and EU, and the company continues trials for additional indications.

Novavax, Inc. (Nasdaq: NVAX) announced on Nov. 18, 2022, that Health Canada has granted expanded authorization for its COVID-19 vaccine, Nuvaxovid™, as a homologous booster for adults aged 18 and over. The authorization is based on Phase 2 and Phase 3 clinical trial data demonstrating increased immune responses comparable to earlier protections against COVID-19. Adverse reactions were generally mild to moderate, with injection site tenderness and fatigue being the most common. Nuvaxovid is now authorized in multiple countries, highlighting its global acceptance as a booster option.

Novavax, Inc. (Nasdaq: NVAX), focused on next-generation vaccines, will participate in the Jefferies London Healthcare Conference on November 16, 2022. Key discussions will center around NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine. The fireside chat is scheduled from 8:35 to 9:05 a.m. GMT in London. The company will also hold investor meetings from November 16 to 17. A replay of the session will be available on Novavax's website for 90 days post-conference.

Novavax, Inc. (NASDAQ: NVAX) announced on November 9, 2022, that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the conditional marketing authorization for its COVID-19 vaccine, Nuvaxovid, to be used as a booster dose. This approval allows its use following a primary vaccination series with Nuvaxovid or other vaccines. The MHRA's decision was informed by data from multiple Phase 2 trials showing strong immune responses to the vaccine, particularly against Omicron variants. The vaccine has shown robust performance as a booster and is already authorized in other regions.

Novavax reported a third-quarter revenue of $735 million, up from $179 million year-over-year, primarily driven by the sale of 35 million doses of its COVID-19 vaccine, NVX-CoV2373. The company refined its full-year revenue guidance to approximately $2.0 billion, aligned with strong booster authorizations and clinical trial advancements. The firm has delivered over 94 million doses globally and initiated a Phase 2b/3 trial for younger children. However, it recorded a net loss of $169 million and faced $435 million in costs, impacting profitability.

Novavax announced positive topline results from its Phase 3 trial of the BA.1 COVID-19 vaccine candidate, NVX-CoV2515, which met the primary strain-change endpoint, indicating capability for developing variant vaccines. The trial demonstrated a strong immune response from the BA.1 candidate, surpassing the prototype vaccine's performance in unexposed individuals. However, the bivalent vaccine showed no additional benefit compared to the prototype. All formulations were well-tolerated, with consistent safety profiles. The ongoing research supports potential adaptability in the evolving COVID-19 landscape.