DBV Technologies reported positive top‑line results from the pivotal Phase 3 Vitesse study: Viaskin Peanut met its primary endpoint in children aged 4–7, with 46.6% meeting responder criteria versus 14.8% for placebo after 12 months. The company plans a Biologics License Application in the first half of next year and said prior FDA feedback and a breakthrough designation support an expedited path. The therapy delivers trace peanut antigen via a skin patch to induce desensitization; common adverse events were mild‑to‑moderate skin reactions. Two treatment‑related anaphylaxis cases occurred but both subjects continued therapy. DBV emphasized the trial’s size and design as addressing historic regulatory concerns. A successful BLA would mark the first approved patch immunotherapy for peanut allergy in young children and could reshape pediatric allergy management. Payers and clinicians will examine durability, safety, and real‑world adherence post‑approval.