2023-08-14 07:39:00
Bad day for the French laboratory Valneva. 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. In question ? The postponement of the FDA review date of its chikungunya vaccine from late August to late November. A postponement is intended to “allow the parties time to agree on the Phase 4 trial program required under the accelerated authorization procedure”, Valneva explained in a press release on August 14.
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. The FDA’s decision, however, has no impact on Valneva’s current regulatory submission in Canada or that planned with the European Medicines Agency, Rx Securities said.
VOS INDICES
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The company said Aug. 14 to continue 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.
With Archyde.com (Gaëlle Sheehan, with the contribution of Pierre John Felcenloben, edited by Kate Entringer)
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