0QAJ Company Report

Analyst Coverage

Research analysts covering 0QAJ.

Recent press releases and 8-K filings for 0QAJ.

DBV Technologies Announces Positive Phase III VITESSE Trial Results

0QAJ

Product Launch

New Projects/Investments

DBV Technologies announced positive top-line results from its pivotal Phase III VITESSE clinical trial for the Viaskin Peanut patch in children aged four to seven years old.
The trial met its primary endpoint, with 46.6% of subjects treated with Viaskin Peanut meeting response criteria at 12 months, compared to 14.8% in the placebo arm, demonstrating a statistically significant treatment effect of 31.8%.
The Viaskin Peanut patch was found to be safe and well tolerated, with safety results consistent with previous studies, including low rates of discontinuations due to treatment-emergent adverse events (3.2%) and treatment-related anaphylaxis (0.5%).
A Biologics License Application (BLA) submission for this age group is planned for the first half of 2026, with potential for priority review.
The positive VITESSE results accelerate the exercise period for warrants from a March 2025 financing, potentially providing up to an additional EUR 168.2 million, which is expected to fund the company through BLA submission and commercial launch, if approved.

Dec 16, 2025, 10:00 PM

DBV Technologies Announces Positive Phase III VITESSE Clinical Trial Results

0QAJ

Product Launch

New Projects/Investments

DBV Technologies reported positive top-line results from its pivotal Phase III VITESSE clinical trial for the VIASKIN Peanut patch in children aged four to seven years.
The trial met its primary endpoint, with 46.6% of subjects treated with VIASKIN Peanut meeting response criteria at 12 months, compared to 14.8% in the placebo arm, demonstrating a treatment effect of 31.8%. The lower bound of the 95% confidence interval was 24.5%, surpassing the FDA's pre-specified threshold of 15%.
The VIASKIN Peanut patch was safe and well tolerated, with safety results consistent with prior clinical programs, and low discontinuations due to treatment-emergent adverse events at 3.2% in the treatment arm.
These results pave the way for a Biologics License Application (BLA) submission in the first half of 2026, with potential for priority review.
The positive VITESSE results accelerate the exercise period for warrants from a March financing, potentially providing up to an additional EUR 168.2 million and funding the company through BLA submission and commercial launch, if approved.

Dec 16, 2025, 10:00 PM

DBV Technologies Announces Positive Phase III VITESSE Trial Results for Viaskin Peanut Patch

0QAJ

Product Launch

New Projects/Investments

DBV Technologies announced positive top-line results from its Phase III VITESSE clinical trial for the Viaskin Peanut patch in children aged four to seven years old, successfully meeting its primary endpoint.
In the trial, 46.6% of subjects treated with the Viaskin Peanut patch met response criteria at 12 months, compared to 14.8% in the placebo arm, demonstrating a statistically significant treatment effect of 31.8%. The patch was also found to be safe and well tolerated.
The company plans to submit a Biologics License Application (BLA) for this age group in the first half of 2026, with potential for priority review.
The positive VITESSE results accelerated the exercise period for warrants, which could provide an additional EUR 168.2 million by January 15, 2026. This, along with EUR 116.3 million already received, is expected to fund the company through BLA submission and commercial launch for the four-to-seven-year-old age group, if approved.
If approved, the Viaskin Peanut patch for both the four-to-seven-year-old and one-to-three-year-old age groups (BLA anticipated in H2 2026) could address approximately 670,000 children with peanut allergy in the U.S..

Dec 16, 2025, 10:00 PM

DBV Provides Update on Peanut Allergy Programs and Regulatory Timelines

0QAJ

Product Launch

Guidance Update

New Projects/Investments

DBV is advancing its novel epicutaneous immunotherapy (EPIT) patch for peanut allergy, with two distinct programs targeting children aged 4-7 years and 1-3 years.
The company anticipates filing a Biologics License Application (BLA) for the 4-7 year old age group in the first half of 2026, with VITESSE trial data readout expected before the end of 2025.
A separate BLA for the 1-3 year old age group is projected for the second half of 2026, pending the completion of the COMFORT Toddlers safety study.
DBV reports sufficient cash to fund operations until the end of 2026, with a potential $181 million from warrant exercise contingent on positive VITESSE trial results.