VLA Valneva SE

By Maitane Sardon

Shares in Valneva plunged in early trading Monday after the French biotech company said the U.S. Food and Drug Administration has delayed the target date for completing the regulatory review of the marketing application for its Chikungunya vaccine candidate.

At 0713 GMT, shares were down 8.5% at EUR6.14 after falling as much as 12% at open.

The review is now set for the end of November and not the end of August as initially planned, Valneva said.

The FDA extended the date to allow sufficient time to align and agree on the Phase 4 trial program required under the accelerated approval pathway, the company said.

The agency hasn't requested any additional clinical data for the approval process, Valneva added.

Write to Maitane Sardon at maitane.sardon@wsj.com

(END) Dow Jones Newswires

August 14, 2023 03:40 ET (07:40 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.