Novavax Inc Stock Price, News & Analysis

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.

Novavax, Inc. (Nasdaq: NVAX) has appointed Richard Rodgers as an independent director on its board. Rodgers brings extensive biopharmaceutical management experience, having co-founded and led several successful biotech firms. The company emphasizes that his expertise will be crucial as it continues to commercialize its COVID-19 vaccine and expand its vaccine pipeline. Novavax has numerous vaccine candidates, including the COVID-19-Influenza Combination vaccine, currently under development. The appointment is seen as a strategic move for the company's future growth and vaccine commercialization efforts.

Novavax, Inc. (Nasdaq: NVAX) will report its third quarter 2022 financial results on November 8, 2022, after the U.S. market closes. A conference call will be held at 4:30 p.m. EDT, with dial-in options available for both domestic and international participants. A replay of the call will be accessible from 7:30 p.m. EDT on the same day until November 15, 2022. Novavax continues to develop innovative vaccines, including its COVID-19 vaccine and other candidates currently undergoing clinical trials.

Novavax presented new data from its Phase 3 PREVENT-19 trial at IDWeek 2022, highlighting the effectiveness of its COVID-19 vaccine (NVX-CoV2373) as a booster for adults. The study demonstrated significant increases in anti-spike antibody responses, regardless of age or booster intervals (8 or 11 months). Additionally, data from a Phase 1/2 trial on a COVID-19-Influenza Combination vaccine showed positive antibody and T-cell responses against multiple strains. The company's growing vaccine portfolio aims to address global health needs amidst ongoing evaluation by regulatory authorities.