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| Name | Symbol | Market | Type |
|---|---|---|---|
| Valneva SE | NASDAQ:VALN | NASDAQ | Depository Receipt |
| Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 8.84 | 8.27 | 8.39 | 1 | 12:13:08 |
From May 2023 to May 2024
By Maitane Sardon
Valneva said Monday that 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 to the end of November, from end of August previously.
The French biotech company 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 FDA hasn't requested any additional clinical data for the approval process, Valneva added.
Chikungunya is a viral disease transmitted by mosquitoes that causes fever and joint pain, among other symptoms.
Write to Maitane Sardon at maitane.sardon@wsj.com
(END) Dow Jones Newswires
August 14, 2023 02:03 ET (06:03 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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