Novavax

Sanofi's two combination vaccine candidates, NCT06695117 and NCT06695130, received Fast Track designation from the FDA for preventing influenza and COVID-19 in people aged 50+. These candidates combine Sanofi's Fluzone High-Dose or Flublok with Novavax's NVXC19 vaccine. Sanofi and Novavax have a deal for co-marketing NVXC19 from 2025, with Sanofi having sole rights to develop and market the combination with its influenza vaccines. Novavax's NVXC19 shows better tolerability and high efficacy. Sanofi's Vaccines unit has strong sales growth, expecting over €10 billion in annual net sales by 2030.

Novavax has started a Phase 3 trial for its COVID-19-Influenza Combination vaccine and a stand-alone seasonal influenza vaccine, aiming to evaluate their immunogenicity and safety in adults aged 65 and older. The company is working with the FDA to explore accelerated approval and plans to provide updates by Q2 2025.

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 initiated a Phase 3 trial for its COVID-19-Influenza Combination and stand-alone influenza vaccines, targeting adults 65+. The trial assesses immunogenicity and safety against its 2024-2025 COVID-19 vaccine and a licensed influenza vaccine. Novavax seeks FDA accelerated approval, with more details expected by Q2 2025. The trial builds on positive Phase 2 data, evaluating the combination and stand-alone vaccines with Matrix-M adjuvant. Financial guidance for 2025 includes $500M for R&D and SG&A, covering this trial.

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.

Pediatric COVID-19 vaccines under EUA could be at risk if pulled by HHS, unlike fully licensed vaccines.

Alec Stranahan from Bank of America Securities maintains a Hold rating on Vir Biotechnology (VIR) with a $15.00 price target, citing cautious optimism due to promising SOLSTICE trial results and anticipation of ECLIPSE phase 3 trials in 2025 to clarify competitive positioning.

Investors react negatively to Trump's nomination of RFK Jr. for HHS, causing COVID-19 vaccine stocks to tumble, with Moderna and BioNTech seeing significant losses. RFK Jr.'s criticism of COVID-19 vaccines and potential impact on vaccine policy contribute to investor concerns. Psychedelic drug companies, however, see stock increases due to RFK's support for the field.