Valneva SE (VALN) stock prices were down by 9.72% as of the market closing on October 19th, 2021. This brought the price per share down to USD$35.40. Subsequent premarket fluctuations saw the stock rise by 8.56%, bringing it up to USD$38.43.
October 18th, 2021 saw VALN stock announce positive topline results from the Phase 3 pivotal trial Cov-Compare. The trial is designed to evaluate the company’s inactivated, adjuvanted Covid-19 vaccine candidate, VLA2001. The clinical study recruited a total of 4,012 participants above the age of 17 across a total of 26 trial sites across the United Kingdom. The trial met its co-primary endpoints, the first of which was the demonstration of VLA2001’s superiority against AZD1222 in terms of geometric mean titer for neutralization antibodies. The second co-primary endpoint was the exhibition of non-inferiority in terms of seroconversion rates at two weeks after the second vaccination, on day 43 of the regimen, in adults above the age of 29.
Details of the Trial
T-cell responses analyzed in a sub-set of participants showed the treatment having induced broad antigen-specific IFN-gamma producing T-cells reactions against the S-, N-, and M- protein. The treatment was generally well-tolerated, with its tolerability profile of VLA2001 being substantially more favorable as compared to the active comparator vaccine. Participants above the age of 29 reported experiencing substantially reduced solicited adverse events within seven days of the vaccination. This is both in regard to injection site reactions and systemic reactions. No unsolicited treatment-related SAEs were reported, while less than 1% of the patient population reporting an adverse event of special interest in either treatment group.
VALN Stock Seeks Approval
VALN stock initiated rolling submission for initial approval with the United Kingdom’s Medicines and Healthcare products Regulatory Agency. The company is taking steps to prepare for the rolling submission for condition approval with the European Medicines Agency. A prerequisite for the final submission of the clinical study report is a final assay validation required by the MHRA. This assay validation serves to verify the integrity of the VLA2001-301 data, with the process currently underway.
Future Outlook for VALN Stock
The company is keen to push for the accelerated development and commercialization of its proprietary VLA2001 treatment. VALN stock is poised to capitalize on the momentum being generated around the world in regard to VLA2001. Current and potential investors are confident in management’s ability to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value over the long term.