DBV Technologies reports positive Phase 3 VITESSE results; BLA submission on track for H1 2026

DBV Technologies S.A.

VITESSE met primary endpoint: response rate 46.6% vs 14.8% placebo (p<0.001); lower bound CI 24.5% >15% threshold.
Safety consistent with prior studies: low discontinuations (3.2% active vs 0.5% placebo), no treatment-related SAEs.
BLA submission for 4-7 year olds planned for first half 2026; prior FDA Breakthrough Therapy Designation.
Positive results trigger acceleration of ABSA and BS warrants exercise period through Jan 15, 2026.
654 children enrolled, largest food allergy immunotherapy trial; compliance 96.2%.

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