DBV Technologies announced that its VITESSE Phase 3 study of the Viaskin Peanut patch met its primary endpoint, enrolling 654 children aged 4 to 7 years. The active treatment arm achieved a 46.6% responder rate at 12 months, compared with 14.8% in the placebo group, a difference of 31.8 percentage points that exceeds the 15% threshold set by the FDA and yields a statistically significant treatment effect.
Safety data from the trial were encouraging. Mild‑to‑moderate local skin reactions were the most common adverse events, and only 3.2% of participants in the treatment arm discontinued because of adverse events versus 0.5% in the placebo group. No serious treatment‑related adverse events were reported, and anaphylaxis occurred in just 0.5% (two patients) of the active group.
Compliance with the patch regimen was high, with 96.2% of participants completing the 12‑month course. The strong adherence rate suggests that the patch is well tolerated and easy to use in the target pediatric population, supporting its potential for real‑world uptake.
The company plans to file a Biologics License Application in the United States in the first half of 2026, leveraging the VITESSE data to accelerate regulatory review. The Viaskin Peanut patch already holds Breakthrough Therapy Designation, and the new data reinforce the company’s dual‑track regulatory strategy, which includes a potential accelerated approval pathway.
Financially, the positive trial results are expected to extend DBV’s cash runway. As of September 30, 2025, the company held $69.8 million in cash and cash equivalents, with estimates that operations could be funded into the second quarter of 2026. The strong efficacy data also support the likelihood of warrant exercises from the March 2025 financing, which could further bolster the balance sheet. However, analysts note that if free cash flow growth continues at historical rates, the runway could shrink to less than a year, underscoring the importance of timely regulatory approval.
The competitive landscape for peanut allergy treatment is evolving. Palforzia, an oral immunotherapy approved in 2020, is reportedly being withdrawn from the market by its manufacturer, creating a gap that Viaskin could fill. Omalizumab, approved in 2024 for multiple food allergies, is administered by injection, whereas Viaskin offers a non‑invasive, self‑applied patch that could appeal to patients and caregivers seeking a simpler regimen.
CEO Daniel Tassé emphasized the significance of the data, stating that “VITESSE is the largest immunotherapy clinical trial ever conducted in food allergy and we are thrilled that the resulting clinical evidence supporting the VIASKIN Peanut patch is robust.” He added that the company is eager to submit the BLA in the first half of 2026 and thanked the FDA for its constructive dialogue. Dr. Pharis Mohideen, chief medical officer, highlighted the FDA’s accelerated approval interest, while Dr. David Fleischer, the global principal investigator, noted that the desensitization levels achieved are “highly clinically meaningful.” Cherie Zachary, president of the American College of Allergy, Asthma and Immunology, praised the trial’s enthusiasm and potential impact on pediatric care.
Historically, DBV faced regulatory setbacks: a withdrawn BLA in 2018, a Complete Response Letter in 2020 due to efficacy concerns related to patch adhesion, and a redesign of the patch formulation for the VITESSE trial. The current success demonstrates that the company has addressed those issues and that the new patch design delivers the required efficacy and safety profile.
Investors responded positively to the trial results, citing the strong efficacy data, favorable safety profile, and clear regulatory pathway as key drivers of the company’s future prospects.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.