DBV Technologies reported positive top‑line results from its pivotal Phase 3 Vitesse trial of the Viaskin peanut patch in children aged 4–7. The study met its primary endpoint: 46.6% of treated children achieved the predefined responder threshold versus 14.8% with placebo. DBV plans to file a Biologics License Application (BLA) with the FDA in the first half of next year. Viaskin delivers small, daily amounts of peanut antigen through intact skin to desensitize the immune system. Safety data showed primarily mild‑to‑moderate local skin reactions; two cases of treatment‑related anaphylaxis were reported but patients continued therapy. The therapy previously faced regulatory setbacks and manufacturing concerns but pursued a redesigned pivotal program to address earlier FDA issues. A U.S. approval would mark a major advance in pediatric food‑allergy immunotherapy and could prompt payer and guideline discussions on access, age indications, and long‑term durability of desensitization.