DBV Technologies surged 59.29% in after-hours trading following the announcement of positive topline results from its Phase 3 VITESSE trial of the VIASKIN® Peanut patch for peanut-allergic children aged 4–7 years. The trial met its primary endpoint, with 46.6% of treated children achieving desensitization compared to 14.8% in the placebo group (difference of 31.8%; 95% CI 24.5–39.0%), exceeding the prespecified threshold. Safety results aligned with prior studies, with mild-to-moderate adverse events and no serious treatment-related issues. The company plans a Biologics License Application submission in H1 2026, potentially eligible for FDA priority review. The positive data also accelerated the exercise period for warrants from its March 2025 financing, enhancing investor confidence. The results underscore the patch’s potential as a non-invasive treatment for peanut allergies, positioning DBV for regulatory milestones and market expansion.
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