DBV completes VITESSE Phase 3 screening early; topline data expected Q4 2025

DBV Technologies S.A.

Screening closed in August 2024, ahead of schedule; enrollment exceeded original goal.
VITESSE enrolled >600 peanut-allergic children ages 4-7 across 86 sites in U.S., Canada, Europe, UK, Australia.
Subjects randomized 2:1 to active Viaskin Peanut Patch vs placebo; 12-month study.
Largest immunotherapy trial in peanut allergy; DBV targets Biologic License Application submission after data.
Topline efficacy and safety results from VITESSE expected by Q4 2025.

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