UK revokes marketing authorization for Valneva’s IXCHIQ vaccine

Valneva SE (VALN) shares fell ~5% after the UK revoked the marketing authorization for its chikungunya vaccine, Ixchiq, due to safety concerns, according to the company. The vaccine was launched in 2023 and is the first of its kind. The move impacts Valneva's revenue and market position in the vaccine sector.

Valneva's stock (VALN) fell 7% after hours as the UK revoked authorization for its IXCHIQ vaccine. The company had previously cut its 2026 sales outlook to €135M-€150M, citing weak demand. VALN stock is down 33% year-to-date, with neutral retail sentiment.

Valneva SE ADR stock fell 5.9% to $5.53 after the UK revoked its chikungunya vaccine's marketing authorization. The company stated the financial impact is limited and no recall costs are expected. The European Medicines Agency and Health Canada maintained the vaccine's authorizations. The stock is trading near its 52-week low of $4.75.

Valneva SE ADRs (VALN) dropped 6.5% after the UK revoked IXCHIQ's marketing authorization due to a benefit-risk review. The MHRA's decision was based on existing safety data, not new signals. The revocation does not affect IXCHIQ's licenses in other regions. Valneva expects minimal financial impact and will not appeal, focusing on endemic territories. Approximately 187,000 doses have been administered globally.

Valneva SE (VLA) announced the UK MHRA revoked IXCHIQ's marketing authorization following a review of prior safety data. The decision does not affect other markets and is not linked to new safety concerns. Valneva expects minimal revenue impact and no recall costs, according to the company.

Pfizer (PFE) and Valneva (VALN) announced the EMA has started reviewing their Lyme disease vaccine candidate, PF-07307405, based on Phase 3 trial data showing over 70% efficacy. The trial met one statistical criterion but not the primary endpoint. Pfizer will commercialize the vaccine if approved, while Valneva benefits as a development partner.