By Giulia Petroni
Valneva SE’s shares rose Thursday after the European Union’s medicine agency accepted the filing of a marketing authorization application for the French pharmaceutical company’s Covid-19 vaccine candidate.
At 0822 GMT, shares were up 11% at EUR11.10.
Acceptance of the filing means Valneva’s candidate VLA2001 is advancing from the rolling review process and beginning the formal review process by European Medicines Agency’s committee for human medicinal products, the company said.
If the committee gives a positive opinion, the European Commission will review the recommendation and provide a final decision on the application.
Earlier this week, Valneva said it received a notice that the EC wanted to terminate an advanced purchase agreement for the vaccine, and that it had 30 days from May 13 to obtain a marketing authorization from the EMA or propose an acceptable remediation plan. Otherwise, the EC would have had the right to terminate the purchase agreement.
Valneva has developed a whole-virus, inactivated Covid-19 vaccine, considered a more traditional type than the vaccines developed by Moderna Inc., Pfizer Inc. and BioNTech SE, and others.
Write to Giulia Petroni at email@example.com