NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) and Valneva SE (VALN) said Friday that the European Medicines Agency (EMA) has validated their Marketing Authorization Application for PF-07307405, a Lyme disease vaccine candidate, allowing the regulator to begin its assessment.
The application is supported by efficacy of more than 70% in the Phase 3 VALOR trial, which evaluated whether PF-07307405 could prevent Lyme disease in individuals aged five years and older. The vaccine was well tolerated, with no safety concerns identified during the trial.
Valneva shares rose nearly 13% in after-hours trading after closing at $5.65 on Thursday, while Pfizer shares gained 1.86% to close at $26.80.
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