(Update: analyst comments, stock market reaction)
PARIS (Agefi-Dow Jones)–The biotechnology company Valneva said on Thursday that the European Medicines Agency (EMA) had accepted the submission of the marketing authorization dossier for its inactivated whole-virus vaccine against Covid-19, VLA2001.
In response, Valneva shares rose 6.5% on Thursday to 10.68 euros.
“The acceptance of the dossier means that VLA2001 leaves the process of progressive review of the data to enter the formal process of evaluation by the Committee for Medicinal Products for Human Use (CHMP) of the EMA,” Valneva said in a press release. “If the CHMP accepts Valneva’s conditional marketing authorization application, the company confirms that it could obtain a positive opinion from the CHMP in June 2022”, added the biotech.
If the CHMP issues a positive opinion, the European Commission will then review the recommendation and make a final decision on the marketing authorization for VLA2001.
In the favorable case where the CHMP issues a positive opinion, the European Commission will examine the recommendation and make a final decision on the marketing authorization, “provided that this opinion arrives before June 12 in accordance with the activated clause of the contract”, emphasizes Invest Securities.
Valneva announced on Monday that it had received from the European Commission a notice of intent to terminate the agreement to supply its vaccine against Covid-19. “Under the terms of the contract, Valneva has 30 days from May 13, 2022 to obtain marketing authorization or to propose a plan to remedy the situation in an acceptable manner”, had then warned the biotech.
A remediation plan is also conceivable for Valneva within the same period, with the aim of agreeing on a ‘compromise’ and possibly contracting directly with certain Member States who request it to receive doses of the vaccine” from the French biotech, Invest Securities added.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: VLV
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May 19, 2022 03:30 ET (07:30 GMT)