DBVT Soars On Positive Phase 3 Trial Of VIASKIN Peanut Patch

(RTTNews) - DBV Technologies (DBVT) yesterday announced positive topline results from its pivotal Phase 3 VITESSE clinical trial, evaluating VIASKIN Peanut patch in children aged 4 to 7 years.

Peanut allergy is one of the most common and burdensome food allergies in children, often requiring strict avoidance and emergency preparedness. Current treatment options remain limited, leaving families with significant unmet needs.

The Phase 3 VITESSE study was a global, randomized, double-blind, placebo-controlled trial that enrolled 654 children across 86 sites. Participants were randomized 2:1 to receive either the VIASKIN Peanut Patch or placebo for 12 months. The primary endpoint measured the percentage of treatment responders, defined by improved eliciting dose thresholds during double-blind, placebo-controlled food challenges.

Results showed that 46.6% of children treated with VIASKIN Peanut Patch met responder criteria at 12 months, compared to 14.8% in the placebo arm. The difference in response rates was 31.8%, exceeding the prespecified threshold of 15% and demonstrating a statistically significant treatment effect.

Safety outcomes were consistent with prior studies, with most adverse events limited to mild-to-moderate local skin reactions. Discontinuations were low, and treatment- related anaphylaxis was rare (0.5%).

Following the double-blind period, children were offered entry into an open-label extension to continue treatment for up to three years. Compliance was high at 96.2%, underscoring the feasibility of long-term use.

The company plans to submit a BLA to the U.S. FDA in the first half of 2026. The VIASKIN Peanut Patch has already received Breakthrough Therapy Designation, and DBV expects the filing may be eligible for priority review.

The achievement of the primary endpoint also triggered an acceleration of the exercise period for warrants issued in DBV's March 2025 financing. As a result, the ABSA and BS Warrants are now exercisable through January 15, 2026, potentially adding up to €168.2 million in gross proceeds to the company's balance sheet.

Upcoming milestones:

•Presentation of full VITESSE results at future medical congresses and submission to peer-reviewed journals.

•Continuation of open-label extension to assess long-term efficacy and safety.

•Ongoing clinical trials of VIASKIN Peanut Patch in toddlers ages 1-3 years.

The company ended September 30, 2025, with cash of $69.8 million, providing runway into the third quarter of 2026.

DBVT was trading at $13.34 when we updated our readers on November 12, 2025.

The stock has traded between $2.74 to $21.50 over the past year. DBVT closed yesterday's trading at $17.98, down 1.69%, and rose in overnight trading to $28.33, up 57.56%, touching a new 52-week high.