Overview
- DBV Technologies reported that 46.6% of children aged 4–7 on the Viaskin Peanut patch met responder criteria at 12 months versus 14.8% on placebo.
- Investigators defined response by increases in eliciting dose measured via double‑blind, placebo‑controlled food challenges.
- The VITESSE trial enrolled 654 participants, randomizing 438 to active therapy and 216 to placebo, and achieved 96.2% overall compliance.
- Safety findings were consistent with prior studies, with mainly local skin reactions, no treatment‑related serious adverse events, and treatment‑related anaphylaxis in 0.5% of patients (n=2), both of whom continued therapy.
- DBV said it plans a U.S. Biologics License Application in the first half of 2026, and shares jumped to a new 52‑week high on the news.