DBV gains FDA alignment on Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years

DBV Technologies S.A.

FDA confirmed Phase 3 EPITOPE efficacy data serves as intermediate endpoint for Accelerated Approval.
COMFORT Toddlers safety study on-track for 2Q 2025 start; will enroll ~480 subjects at 80-90 centers.
Post-marketing confirmatory study criteria agreed; BLA submission for toddlers anticipated 2H 2026.
Commercial Viaskin Peanut patch (used in 304 subjects OLE) deemed different product; no safety/efficacy differences vs clinical patch.
Adhesion will be exploratory endpoint in COMFORT Toddlers, not co-objective; wear time data methodology aligned with FDA.

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