Valneva Initiates Rolling Submission For COVID19 Vaccine Candidate In UK

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  • Valneva SE VALN has commenced rolling submission for its COVID-19 vaccine candidate with the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K.
  • The candidate dubbed VLA2001 is a whole virus, inactivated, adjuvanted vaccine candidate.
  • VLA2001 is currently being studied in the U.K. in a Phase 3 Cov-Compare (VLA2001-301) trial.
  • Topline results are expected early in Q4 of 2021. 
  • Subject to positive Cov-Compare data and MHRA review, Valneva believes that initial approval could be granted by the end of 2021.
  • In September 2020, Valneva announced a collaboration with the U.K. Government, which has the option to purchase up to 190 million doses through 2025. 
  • So far, the U.K. Government has ordered 100 million doses for supply in 2021 and 2022.
  • VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and Dynavax Technologies Corp's DVAX CpG 1018.
  • Price Action: VALN shares are up 4.10% at $30.20 during the premarket session on the last check Monday.
Posted In: BiotechLong IdeasNewsHealth CareSmall CapMoversTrading IdeasGeneralBriefsCoronavirusCOVID-19 Vaccine
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