DBV Technologies said it has engaged in an extensive, iterative dialogue (repeating the same process) with U.S. health authorities, with the aim of ensuring a thorough, efficient and timely review of its upcoming Biologics License Application (BLA) in children aged 4 to 7.

Following discussions (meetings, document submissions, etc.), the French company received "valuable and actionable feedback, specifically related to the organization, structuring and formatting of existing data for the CMC and biostatistics components of the Biologics License Application (BLA)." DBV Technologies noted that the FDA did not request any additional data.

Following these exchanges, DBV Technologies plans to file the BLA package during the third quarter of 2026.

According to Daniel Tassé, the company's CEO: "the VIASKIN Peanut patch is an innovative, unique and complex product for which there is no regulatory precedent. In that respect, our recent interactions with the FDA were particularly productive in strengthening our Biologics License Application (BLA) package."