DBV Technologies Announces Topline Results From Phase 3 VITESSE Trial of VIASKIN Peanut Patch In Peanut Allergic Children Aged 4-7 Years; VITESSE Met Its Primary Endpoint

DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years

• VITESSE met its primary endpoint: the lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15% 
• 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm 
• Safety results were consistent with the safety profile observed in the VIASKIN Peanut clinical program to date
• BLA submission in 4-7-year-olds on track for the first half of 2026
• Achievement of primary endpoint triggers an acceleration of the exercise period of certain warrants issued pursuant to DBV's March 2025 financing
• DBV to host a conference call today at 5:00 p.m. ET to discuss the VITESSE topline results and path forward

DBV Technologies (TRQX:DBVp), a late-stage biopharmaceutical company, today announced that VITESSE, its pivotal Phase 3 study assessing the safety and efficacy of VIASKIN® Peanut patch for the treatment of peanut-allergic children aged 4 to 7 years, met its primary endpoint.