DBV Technologies reported positive top‑line results from its pivotal Phase III Vitesse trial of the Viaskin peanut patch in children aged 4–7. The study met its primary endpoint: roughly 46.6% of treated children reached the prespecified desensitization response at 12 months versus 14.8% for placebo. The company plans a biologics license application (BLA) submission in the first half of next year. Vitesse is the largest immunotherapy trial in food allergy history and comes after prior regulatory setbacks for the patch. DBV emphasized a favorable safety profile—mostly local skin reactions—with two treatment‑related anaphylaxis cases that resolved and did not halt therapy. The result represents a comeback narrative for the company and clears a key path toward U.S. approval and commercial rollout. DBV will need to address past manufacturing and quality concerns in its regulatory filing. If cleared, Viaskin would enter a largely unmet pediatric allergy space and could change desensitization approaches for food allergy management.