DBV Technologies S.A.
For the period ended Oct 28, 2026. Filed Oct 28, 2026.
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A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
Oct 28, 2026 · Filed Oct 28, 2026
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Contents
EX-99.1 · Toddler Program
Toddler Program
| • | DBV has held discussions with the Agency on how to ensure a timely review of the BLA for toddlers aged 1 through 3 years following the recent submission of the 4-through-7 BLA, including a potential rolling submission of the 1-through-3 BLA. The same review Team will review both BLAs. FDA indicated that a review of the 1-through-3 BLA initiated shortly after the review of the 4-through-7 BLA would allow the Agency to build on the learnings from their review and the efficiencies expected from the meaningful content overlap of the two BLAs. It would provide DBV and FDA the opportunity to align on the form, content, and best timing of the components of the 1-through-3 BLA submission, in support of an efficient review of both BLAs. |
| • | DBV will continue the regulatory dialogue with FDA over the next few months and expects to submit the toddler BLA in 2027. DBV will provide an update once the FDA discussions regarding the Company’s toddler program have been finalized. |
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