Viaskin Peanut - (VITESSE)

March 26, 2026: DBV Technologies (Nasdaq: DBVT; Euronext: DBV) reported full-year 2025 results and provided a business update focused on the VIASKIN® Peanut Patch epicutaneous immunotherapy programs in peanut-allergic children.

VIASKIN Peanut Patch (ages 4–7): The company reported positive topline results from the Phase 3 VITESSE trial (previously announced Dec. 16, 2025) in peanut-allergic children aged 4–7 years. DBV anticipates submitting a Biologics License Application (BLA) for this age group in the first half of 2026, with potential for Priority Review.

VIASKIN Peanut Patch (ages 1–3): DBV initiated the COMFORT Toddlers supplemental safety study in peanut-allergic toddlers aged 1–3 years. Upcoming catalysts include completion of enrollment and a subsequent topline readout in 2026. A BLA submission for ages 1–3 is anticipated in the second half of 2026 under an Accelerated Approval pathway.

Additional planned study: DBV announced plans for a study in peanut-allergic infants (6–12 months) to assess efficacy/safety for achieving ad lib dietary peanut consumption after ≥3 years of treatment.

Financing/runway: Cash and equivalents were $194.2M at Dec. 31, 2025, plus $94M gross proceeds received in January 2026, expected to fund operations into Q2 2027.