Novavax Inc - NVAX STOCK NEWS

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.

Novavax, Inc. (Nasdaq: NVAX) announced that its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) received Emergency Use Authorization (EUA) from the FDA for a first booster dose for adults 18+ who cannot receive or opt not to receive an FDA-authorized mRNA booster. The EUA is based on Phase 3 trial data showing significant increases in antibody levels post-booster. The vaccine has been authorized in various countries and can help boost vaccination rates, particularly among adults who have not yet received their first booster.

Novavax (Nasdaq: NVAX) has announced positive results from its Phase 1/2 trial of a COVID-19-Influenza Combination (CIC) vaccine. This innovative trial is the first to evaluate a combined vaccine for COVID-19 and influenza. Data showed robust immune responses, including antibodies and polyfunctional T-cells against SARS-CoV-2 and various influenza strains. The CIC demonstrated a safety profile consistent with standalone vaccines, with rare serious adverse events. Results will inform a Phase 2 confirmation trial scheduled for late 2022.

Novavax presented significant data at the World Vaccine Congress Europe 2022, demonstrating its prototype COVID-19 vaccine, NVX-CoV2373, effectively induced robust antibody responses against Omicron variants BA.1, BA.2, and BA.5. Study 307 confirmed the consistency of immune responses across three vaccine lots. The PREVENT-19 trial showed a significant rise in antibody levels after booster doses in adults and adolescents, suggesting promising protective efficacy against COVID-19 variants. The findings indicate a solid safety profile, enhancing confidence in the vaccine's potential effectiveness as a booster.

On October 10, 2022, Novavax (Nasdaq: NVAX) announced it will present new data on its COVID-19-Influenza Combination vaccine and COVID-19 booster at the World Vaccine Congress Europe from October 11-14, 2022. The data will showcase the vaccine's safety and immunogenicity, reinforcing its use in adults and adolescents. Additionally, Novavax will present updated Phase 3 data from the PREVENT-19 trial, demonstrating the effectiveness of its COVID-19 vaccine as a heterologous booster. Gregory Glenn, M.D., will also participate in a keynote panel discussing the future of COVID vaccination.