DBV Technologies Provides BLA Submission Update for the VIASKIN® Peanut Patch in Children Aged 4 through 7 Years; Working Collaboratively with FDA to Optimize Review Process in Preparation for Filing

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Châtillon, France, June 29, 2026DBV Technologies Provides BLA Submission Update for the VIASKIN® Peanut Patch in Children Aged 4 through 7 Years; Working Collaboratively with FDA to Optimize Review Process in Preparation for Filing DBV has been engaged in extensive discussions with the FDA in preparation of its BLA for the VIASKIN® Peanut Patch in children aged four through seven yearsThe objective of the detailed, iterative engagement was to ensure a complete, efficient, and timely FDA review of the BLA, once submittedThe Agency has not requested additional dataDBV will take additional time to incorporate the FDA feedback and anticipates submitting the BLA in the third quarter of 2026DBV will host a conference call today, June 29, at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today provided an update on the Biologics License Application (BLA) submission seeking marketing approval of the VIASKIN® Peanut Patch in children aged four through seven years. Over recent weeks, DBV has had ongoing detailed and iterative engagement with the U.S. Food and Drug Administration (FDA) with the objective of ensuring a complete, efficient, and timely review of the Company’s upcoming BLA for children aged four through seven years. DBV and the FDA have collaborated through meetings, information exchanges, and filings for the VIASKIN® Peanut Patch Investigational New Drug Application (IND). Through this process and based on its review, DBV received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The FDA has not requested additional data. The Company will take the required time to incorporate that feedback and now anticipates filing of the BLA to occur in the third quarter of 2026. “The VIASKIN® Peanut Patch is a novel and complex product with no regulatory precedent. As such, our recent dialog with the FDA has been especially productive to enhance our BLA submission,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “Our extensive and detailed conversations with the FDA are the kind of discussions a sponsor would anticipate following submission of a BLA, so we are grateful for the Agency’s collaboration and constructive engagement prior to filing.”Conf...

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