DBV Technologies, a late-stage biopharmaceutical company, is preparing to submit a Biologics License Application (BLA) for the VIASKIN Peanut Patch in children aged four through seven years in the third quarter of 2026. The company has engaged in detailed discussions with the U.S. Food and Drug Administration (FDA) to optimize the review process, receiving feedback on the organization and formatting of existing data sets for the CMC and biostatistical elements of the application. The FDA has not requested additional data, allowing the company to proceed with filing after incorporating the agency's input.

Daniel Tassé, Chief Executive Officer of DBV Technologies, stated that the VIASKIN Peanut Patch is a novel product with no regulatory precedent. He noted that the recent dialogue with the FDA has been productive, allowing the company to enhance its BLA submission prior to filing. Tassé expressed gratitude for the agency's collaboration and constructive engagement during this preparatory phase.

Key Details of the BLA Update

DBV Technologies is focused on developing treatment options for food allergies and other immunologic conditions using its proprietary VIASKIN Patch technology. The company's programs include ongoing clinical trials of the VIASKIN Peanut Patch in peanut-allergic toddlers and children. DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ.

DBV Technologies will present new positive data from its Phase 3 VITESSE study and the design of its recently initiated Phase 2 THRIVE study at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026. The event is scheduled for June 12 – 15, 2026, in Istanbul, Turkey. The presentations focus on the efficacy and safety of the VIASKIN Peanut Patch across different pediatric age groups.

In the Phase 3 VITESSE study, the VIASKIN Peanut Patch demonstrated statistically significant efficacy compared to placebo in children ages 4 through 7 years with peanut allergy. This efficacy was specifically observed in subgroups of children who also had another common atopic condition, such as asthma, concomitant food allergy, or atopic dermatitis.

DBV Technologies will also provide a preview of the clinical trial design for its Phase 2 THRIVE study. This study will assess the efficacy and safety of the VIASKIN Peanut Patch in achieving ad lib consumption of peanuts in infants ages 6 through 12 months with peanut allergy. The assessment will follow three years of treatment.

The following table outlines the key details of the studies being presented:

Both studies will be featured in oral abstract sessions at the congress.