Valneva and Pfizer Lyme vaccine candidate enters EMA review

The European Medicines Agency (EMA) has validated the marketing authorization application for PF-07307405, an investigational Lyme disease vaccine candidate developed by Pfizer and Valneva. This validation allows the application to enter the formal scientific assessment process in the European Union. The vaccine, which targets the OspA protein, demonstrated over 70% efficacy in the Phase 3 VALOR trial involving more than 9,000 participants across the US, Canada, and Europe.

Following the regulatory news, Valneva shares experienced a significant surge, rising 24% in a single day. Despite the positive regulatory milestone, Valneva’s recent financial reports showed a first-half 2026 revenue of €65.8 million, down from €97.6 million in the same period last year, partly due to the planned wind-down of third-party sales. The company reported an earnings per share (EPS) of -$0.40, missing consensus estimates of -$0.23.

Valneva reaffirmed its full-year 2026 guidance of €135 million to €150 million and maintains a solid cash position of €121.5 million. If approved, Pfizer will hold exclusive rights to manufacture and commercialize the vaccine.