(Reuters) – Valneva shares fell on the stock market on Monday after the U.S. drug administration (FDA) decided to postpone the target date for the regulatory review of its Chikungunya vaccine.
On the Paris Stock Exchange, around 08:25 GMT, the action of the French drug manufacturer yielded 9.71% to 6.06 euros at 09:18 GMT.
The postponement of the FDA review date from late August to late November is intended to “allow the parties time to agree on the Phase 4 trial program required under the review process. ‘accelerated clearance,'” Valneva said in a statement on Monday.
In a note, analysts at Rx Securities say designing phase 4 vaccine development is made difficult “due to the complexity and cost of disease prevention trials.”
“While this delay is modest, the FDA has not requested additional data to complete its review,” adds Rx Securities.
However, the FDA’s decision has no impact on Valneva’s current regulatory submission in Canada or that planned for the European Medicines Agency, Rx Securities said.
The company said Monday it continues to plan for “possible approval of its marketing application” as well as an initial product launch and potential award of a priority review voucher for 2023.
(Written by Gaëlle Sheehan, with contributions from Pierre John Felcenloben, editing by Kate Entringer)
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