Development And Regulatory 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.
FDA And Program UncertaintyThe stock pullback due to FDA ambiguity/program uncertainty for Ixchiq is justified.
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.