DBV Technologies (Euronext:DBV - Nasdaq: DBVT) shares rose 7.9% on Monday after the company presented additional results from its Phase 3 VITESSE trial during the American Academy of Allergy, Asthma, and Immunology 2026 Annual Meeting.
The newly disclosed data showed that about 83% of children treated with the VIASKIN Peanut Patch increased their eliciting dose at month 12, compared with around 48% in the placebo arm. In addition, roughly 60% of treated children raised their eliciting dose by at least two dose levels at month 12, versus 23% among those who received placebo.
DBV described VITESSE as the largest food allergy immunotherapy trial conducted to date. The study enrolled peanut-allergic children aged 4 to 7 years and met its primary endpoint: 46.6% of children in the VIASKIN Peanut arm met treatment responder criteria at 12 months, compared with 14.8% in the placebo arm.
The data also highlighted differences in declines of sensitivity. Some 24% of children on placebo experienced a decrease in their eliciting dose between baseline and month 12, while only 6.4% of children treated with the patch showed such a decrease.
Subgroup outcomes by baseline eliciting dose were reported as follows: among children whose baseline eliciting dose was 30 mg or less, 49.3% were responders in the VIASKIN Peanut arm versus 14.7% in the placebo group. For children with a baseline eliciting dose of 100 mg, 43.1% were responders compared with 14.6% in the placebo arm.
Safety observations for the VITESSE trial were consistent with the company's prior Phase 3 work. The treatment was generally well tolerated, and the majority of treatment-emergent adverse events were described as mild local application site reactions.
DBV Technologies has announced plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the first half of this year.
Context and market reaction
The data release and presentation at AAAAI correlated with a near-term uptick in DBV shares. The trial results provide additional detail on efficacy by overall responder rates, dose-level improvements and subgroup performance by baseline eliciting dose, as well as reinforcing a tolerability profile dominated by local reactions.
What to watch next
Investors and market participants are likely to monitor the company’s regulatory filing timeline and any further clinical updates or communications that clarify the submission package for the planned Biologics License Application in the first half of the year.