Valneva shares hit 7-month high after EMA validates Lyme vaccine filing

Valneva SE’s shares surged to their highest level since May on Friday after the European Medicines Agency (EMA) validated the company’s key filing for its Lyme disease vaccine candidate, VLA15.

The EMA’s validation confirms the completeness of the submission, triggering the start of the regulatory review process. Valneva’s stock rose as much as 15% in early trading, reaching levels last seen in May, before paring gains to trade 12% higher at €3.90 by midday in Paris.

The vaccine, VLA15, is designed to protect against Lyme disease, a tick-borne illness caused by the bacterium Borrelia burgdorferi. The EMA’s validation follows the U.S. Food and Drug Administration’s (FDA) acceptance of the company’s Investigational New Drug (IND) application for VLA15 in April, which initiated a Phase 3 clinical trial.

Valneva, a specialty vaccine company based in Saint-Herblain, France, has positioned VLA15 as a potential first-in-class vaccine for Lyme disease. The disease is the most common vector-borne illness in the United States, with approximately 476,000 cases diagnosed annually, according to the U.S. Centers for Disease Control and Prevention (CDC).

The EMA’s validation marks a critical milestone in the vaccine’s development, though the regulatory review process remains subject to further assessments. Valneva has not provided a timeline for potential approval, and the vaccine’s commercial viability depends on the outcome of ongoing and future clinical trials as well as regulatory decisions.

The company’s shares have been volatile in recent months amid investor uncertainty over the vaccine’s progress and broader biotech sector trends. Today’s move reflects renewed optimism following the EMA’s validation, which underscores the regulatory pathway for VLA15 ahead of potential market authorization.