DBV Technologies Inc.

VIASKIN® Peanut patch shows improved efficacy in toddlers aged 1-3 over 36 months, with 68.2% completing an oral food challenge without stopping criteria, up from 30.7% at month 12. No serious treatment-related adverse events occurred. Data supports proposed FDA labeling and will be presented at the Eastern Food Allergy & Comorbidity Conference.

DBV Technologies reports positive 3-year results from the EPITOPE Phase 3 study, showing VIASKIN® Peanut patch's efficacy in toddlers aged 1-3 years. 68.2% completed an oral food challenge without meeting stopping criteria at 36 months, up from 30.7% at month 12. No serious adverse events were reported. Data supports VIASKIN's labeling approach with FDA.

DBV Technologies' EPITOPE study shows Viaskin Peanut Patch improves efficacy over 36 months, with 83.5% reaching ≥1000 mg eliciting dose. Low wear time variability correlates with better efficacy. Safety data supports proposed FDA labeling strategy, with no serious treatment-related adverse events in Year 3.

DBV Technologies reported positive 36-month results from the EPITOPE Phase 3 Open-Label Extension Study for VIASKIN® Peanut patch in toddlers, showing improved efficacy and safety. 68.2% of subjects completed an oral food challenge without stopping criteria, up from 30.7% at month 12. No serious adverse events were reported. Data supports VIASKIN's labeling approach, with findings presented at the Eastern Food Allergy & Comorbidity Conference.

VIASKIN® Peanut patch shows improved efficacy in toddlers aged 1-3 years over 36 months, with 68.2% completing oral food challenges without stopping criteria. No serious adverse events reported. DBV Technologies to present findings at Eastern Food Allergy Conference, supporting FDA labeling proposal.

DBV Technologies reported positive 3-year results from the EPITOPE Phase 3 study, showing VIASKIN® Peanut patch's efficacy and safety in toddlers aged 1-3 years. 68.2% completed an oral food challenge without issues, up from 30.7% at month 12. No serious adverse events were reported. Data supports FDA labeling approach.

DBV Technologies announced a clear regulatory pathway for Viaskin Peanut patch in toddlers 1-3 years old via FDA's Accelerated Approval. The company and FDA agreed on key design elements for a post-marketing confirmatory study, aiming to support two distinct BLAs and an MAA in Europe. DBV plans to submit the BLA in 2H 2026.

DBV Technologies aligns with FDA on Accelerated Approval for Viaskin Peanut patch in toddlers 1-3 years-old, with COMFORT Toddlers study set to start in 2Q 2025 and BLA submission anticipated in 2H 2026.

DBV Technologies aligns with FDA on Accelerated Approval for Viaskin® Peanut Patch in toddlers 1-3 years, with COMFORT Toddlers study starting 2Q 2025 and BLA submission expected 2H 2026. FDA confirms criteria for post-marketing study, and DBV modifies patch for commercialization.