DBV Technologies reported that its Viaskin peanut allergy patch met the primary endpoint in the pivotal Vitesse Phase III trial in children aged 4–7, with 46.6% responders on active treatment versus 14.8% on placebo. The result follows a long regulatory slog dating back to prior FDA rejections and manufacturing discussions, and DBV said it will file a U.S. BLA in the first half of next year. The program’s safety profile remained largely skin‑reaction driven; DBV reported two treatment‑related anaphylaxis events but no treatment‑related serious adverse events. Investors reacted strongly, sending shares up on the readout. DBV framed the outcome as the largest immunotherapy study for a food allergy to date and will pursue regulatory engagements that could include priority review given prior breakthrough designation.