Development And Execution RisksKey risks include VLA15 development or regulatory delays, commercial execution risk for IXCHIQ and future launches, and the need for additional funding if milestone or royalty income falls short of projections.
Regulatory ChallengesThe FDA has suspended the license for IXCHIQ following four new reports of serious adverse events, requiring Valneva to halt all shipments and sales of IXCHIQ in the U.S.
Regulatory RisksThere is some potential risk for ex-U.S. regulators to change stance on Ixchiq licensure.