(Update: analyst comment, stock market reaction)
PARIS (Agefi-Dow Jones)–Valneva shares posted one of the biggest gains in the SBF 120 index on Friday, although the biotech company said it was about a month late in the approval process. his vaccine against Covid-19.
Around 3:45 p.m., Valneva shares rose 6.6% to 15.70 euros.
On Friday morning, the biotech announced that it had received a list of additional questions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) following the initial evaluation of its vaccine candidate against Covid-19, VLA2001.
“As announced on February 25, 2022, Valneva received a list of questions as part of the initial assessment from the CHMP and responded to them within two business days of receipt. Valneva has now received a low number of additional questions and expects to ‘respond to them in the coming days,’ the company said in a statement.
Given this series of additional questions and subject to the CHMP’s acceptance of Valneva’s responses, the biotech now expects to receive a positive recommendation from the CHMP for a conditional authorization of VLA2001 for primary vaccination in adults aged 18 to 55 years old in April 2022, and no longer at the end of the first quarter of 2022.
Following this conditional clearance, the company is expected to begin delivering planned doses of VLA2001 to European countries during the second quarter, while first deliveries of the vaccine were previously expected at the start of the second quarter.
With Valneva’s Covid vaccine approval about a month behind schedule, there’s no need to worry, says Bryan, Garnier & Co. “It’s not alarming because it’s been part of the normal EMA review process,” said the financial intermediary.
Valneva has signed an agreement with the European Commission for the supply of up to 60 million doses of VLA2001 over a two-year period, including 24.3 million doses in 2022 and an option to deliver the remaining doses in 2023 The group has already started producing doses of VLA2001 for the European Commission.
-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: ACD – VLV
Agefi-Dow Jones The financial newswire
Dow Jones Newswires
March 11, 2022 09:47 ET (14:47 GMT)