Peanut Allergy Patch For Kids? DBV Technologies Advances Toward FDA Filing

Core Insights - DBV Technologies S.A. has released positive data from the VITESSE Phase 3 study for the VIASKIN Peanut patch, targeting peanut-allergic children aged 4 to 7 years [1][2] Trial Data - The pivotal trial met its primary endpoint, showing a statistically significant treatment effect with 46.6% of children in the VIASKIN Peanut arm meeting treatment responder criteria after 12 months, compared to 14.8% in the placebo arm [2] - Responders were defined as children who increased their eliciting dose (ED) of peanut protein significantly after 12 months, indicating a successful treatment response [3] Study Enrollment and Safety - The VITESSE study enrolled 654 children, surpassing the initial target of 600, with 438 in the active arm and 216 in the placebo arm [4] - Safety results were consistent with previous studies, with mild-to-moderate local skin reactions being the most common treatment-emergent adverse events (TEAEs) [4] - Discontinuation due to TEAEs was low at 3.2% in the treatment arm versus 0.5% in the placebo arm, with no serious treatment-related adverse events reported [5] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) in the United States in the first half of 2026 [6] - Following the trial data release, DBV Technologies shares increased by 35.76% to $24.41, reaching a new 52-week high [6]