Valneva Initiates Rolling Submission For COVID19 Vaccine Candidate In UK

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.