Viaskin Peanut - (VITESSE)

July 16, 2026: DBV Technologies (Nasdaq: DBVT; Euronext Paris: DBV) reported Q2 and half-year 2026 results and provided a regulatory/clinical update for the VIASKIN® Peanut Patch. The company said it continues “productive” and iterative engagement with the FDA to support a complete BLA for VIASKIN Peanut Patch in peanut-allergic children aged 4–7 years; the FDA has not requested additional data. Based on FDA feedback focused on organization/mapping/formatting of existing CMC and biostatistical datasets, DBV now anticipates BLA submission in Q3 2026 (revised from Q2 2026).

Pipeline execution updates: recruitment closed in Q2 2026 for the COMFORT Toddlers supplemental safety study (toddlers 1–3 years). DBV also initiated the THRIVE study in infants 6–12 months with peanut allergy, evaluating efficacy and safety for achieving ad lib dietary peanut consumption after 3–4 years of VIASKIN treatment. DBV noted it presented positive subgroup analyses from the Phase 3 VITESSE study at AAAAI and EAACI.

Financially, cash and cash equivalents were $174.9M as of June 30, 2026, which DBV expects to fund operations into Q3 2027.