Valneva Shares Plunge on FDA Setback for Chikungunya Vaccine (1)

(Adds analyst comments.)

Valneva shares plunge as much as 13%, the most since Sept. 2022, after the French vaccine maker said the US FDA has revised its decision date for the company’s chikungunya virus vaccine candidate.

• Stock pares decline to trade 9.5% lower in Paris on Monday
• The new Prescription Drug User Fee Act (PDUFA) action date is at the end of November, compared with the previously communicated date of end-August
  • The FDA extended the PDUFA date to allow enough time to align and agree on the Phase 4 program necessary under the accelerated approval pathway
  • Valneva says no additional clinical data ...