DBV Technologies Advances BLA Submission for VIASKIN® Peanut Patch

DBV Technologies has provided an update on its Biologics License Application (BLA) submission for the VIASKIN® Peanut Patch, targeting children aged 4 to 7 years. The French biopharmaceutical company has been in extensive discussions with the U.S. Food and Drug Administration (FDA) to ensure a comprehensive review process. Importantly, the FDA has not requested additional data, indicating current information suffices for review.

DBV has taken FDA feedback, focusing on data organization and formatting, and plans to submit the BLA in Q3 2026. CEO Daniel Tassé emphasized the productivity of interactions with the FDA, reflecting on the complex nature of this novel treatment. The company will hold a conference call to elaborate on these developments.