Matrix-M

Novavax achieved a $50 million milestone in its partnership with Sanofi, advancing its COVID-19 vaccine in children and receiving Fast Track designation for combination vaccine candidates. Additional milestones and royalties are potential, solidifying future partnership models.

Novavax initiated a phase III study for its COVID-19-influenza combo and standalone influenza vaccines, targeting adults 65+. Utilizing Matrix-M adjuvant, it aims for FDA accelerated approval, supported by mid-stage study data. Novavax's shares rose 82.7% YTD. Competitors like Pfizer and Moderna are also developing COVID/flu vaccines, with Moderna leading in late-stage development.

Novavax dosed first participants in COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial, aiming to evaluate immunogenicity and safety in adults aged 65+ compared to Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine. The company plans to progress through strategic partnerships and is working with the U.S. FDA for potential accelerated approval.

Novavax dosed first participants in COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial, aiming to evaluate immunogenicity and safety in adults aged 65+. The company plans to progress through strategic partnerships and work with the U.S. FDA for potential accelerated approval. Initial cohort of 2,000 participants is being recruited, with updates expected by Q2 2025.

The FDA has lifted the clinical hold on Novavax's COVID-19-Influenza Combination and stand-alone influenza vaccine candidates, allowing the initiation of a Phase 3 trial. The hold was due to a serious adverse event initially reported as motor neuropathy, later changed to amyotrophic lateral sclerosis, which was assessed as unrelated to the vaccine.

FDA places clinical hold on Novavax's COVID-19-Influenza Combination and stand-alone influenza vaccine candidates due to a serious adverse event reported in a Phase 2 trial participant. Novavax is working with the FDA to resolve the hold and prioritize safety.