DBV Technologies (DBV) Status update summary

Regulatory update and FDA interactions

• Ongoing, detailed discussions with the FDA focused on the Biologics License Application (BLA) for the VIASKIN Peanut patch for children aged four to seven years.

• FDA feedback centered on organization, mapping, and formatting of existing data sets, especially for the CMC section and biostatistical elements.

• No additional data requested by the FDA; feedback is procedural to ensure efficient review.

• Early, pre-filing engagement with the FDA is considered beneficial for streamlining the review process.

BLA submission timeline and process

• BLA submission for the four to seven-year-old indication is now anticipated in Q3 2026 to incorporate FDA feedback.

• Detailed planning and operational rigor, including Gantt charts, are being used to manage the process and ensure timely submission.

• The process includes significant QA/QC to ensure changes are consistently reflected throughout the BLA.

• Submission timeline remains on track for Q3, with no anticipated delays into Q4.

Impact on future filings and other programs

• Lessons learned from the current BLA process will inform and streamline future filings, including for the one to three-year-old population.

• COMFORT Toddler study for one to three-year-olds is enrolling as planned, with BLA submission expected before year-end.

• Ongoing dialogue with the FDA for both current and future submissions.