DBV Technologies announced positive top‑line results from its pivotal Phase 3 Vitesse trial: 46.6% of children treated with the Viaskin peanut patch met the trial’s responder criteria after 12 months versus 14.8% for placebo. The company said it will submit a biologics license application (BLA) to the U.S. FDA in the first half of next year. Viaskin delivers small amounts of peanut antigen transdermally to desensitize children aged 4–7. The result marks a comeback for Viaskin after prior regulatory setbacks and manufacturing concerns that stalled earlier filings. Safety data showed mostly mild‑to‑moderate skin reactions; two instances of treatment‑related anaphylaxis were reported but both patients continued therapy. DBV will pursue regulatory reviews in the U.S. and Europe and may qualify for priority review pathways given breakthrough designations. Commercial success will hinge on payer acceptance and on convincing clinicians to adopt another immunotherapy modality for pediatric food allergy.