Valneva ADRs fall as UK revokes IXCHIQ marketing authorization

Investing.com -- Valneva SE ADRs (NASDAQ: VALN) fell 6.5% in after-hours trading Wednesday after the UK revoked the marketing authorization for its IXCHIQ chikungunya vaccine following a benefit-risk review.

The Medicines and Healthcare products Regulatory Agency (MHRA) revoked the authorization after the UK's Commission on Human Medicines conducted a benefit-risk assessment for travelers. The decision was based on a review of previous safety data and was not associated with any newly identified safety signal, according to the company.

The revocation does not affect product licenses for IXCHIQ in the EU, Canada, Brazil, or other territories where the vaccine is currently marketed.

IXCHIQ was launched in the UK in mid-2025. Due to low sales among travelers, Valneva has not actively distributed the vaccine in the UK for several months. The company said no product currently remains on the UK market and it expects no expense related to product recall and only minimal impact on its overall sales revenue.

Valneva said it considers the benefit-risk profile of IXCHIQ favorable when used in accordance with the approved indication. The company cited emerging post-marketing evidence, including an ongoing pilot vaccination strategy in Brazil where more than 61,000 people aged 18-59 years have been vaccinated with no new safety concerns identified.

Similar safety reviews were concluded recently by the European Medicines Agency and Health Canada, which maintained the marketing authorizations for IXCHIQ with updated product information. To date, approximately 187,000 doses of IXCHIQ have been administered globally.

While Valneva disagrees with the UK regulators' conclusion, the company has decided not to appeal the decision given its immaterial financial and commercial impact. The company said it will maintain its strategic focus on expanding access to IXCHIQ in endemic territories where the risk of chikungunya virus infection is highest.

Original Article

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