Announcement • Jul 01
DBV Technologies Provides BLA Submission Update For The VIASKIN Peanut Patch In Children Aged 4 Through 7 Years DBV Technologies provided an update on the Biologics License Application (BLA) submission seeking marketing approval of the VIASKIN Peanut Patch in children aged four through seven years. Over recent weeks, DBV has had ongoing detailed and iterative engagement with the U.S. Food and Drug Administration (FDA) with the objective of ensuring a complete, efficient, and timely review of the Company’s upcoming BLA for children aged four through seven years. DBV and the FDA have collaborated through meetings, information exchanges, and filings for the VIASKIN Peanut Patch Investigational New Drug Application (IND). Through this process and based on its review, DBV received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The FDA has not requested additional data. The Company will take the required time to incorporate that feedback and now anticipates filing of the BLA to occur in the third quarter of 2026. The VIASKIN Peanut Patch is a novel and complex product with no regulatory precedent. Epicutaneous immunotherapy (EPIT), the VIASKIN Peanut Patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut Patch in toddlers (1 through 3 years of age) and children (4 through 7 years of age) with peanut allergy. DBV
Live News • Jun 30
DBV Technologies Pushes VIASKIN Peanut Patch Filing to Q3 2026 After FDA Feedback DBV Technologies now plans to submit its Biologics License Application for the VIASKIN Peanut Patch in children aged 4 to 7 in Q3 2026, after taking extra time to incorporate feedback from recent discussions with the FDA.
The FDA has not requested additional data, and DBV says the extended timeline is intended to optimize the quality of the filing and the subsequent review process for this key product candidate.
DBV Technologies’ shares trade around €2.86, with the stock down about 21% over the past 90 days, reflecting a period of weaker recent performance.
The longer runway to a potential filing keeps regulatory risk in focus for DBV Technologies, as the VIASKIN Peanut Patch remains central to the company’s story and timeline for potential commercialization. DBV
Live News • Jun 13
DBV Technologies Starts Infant Peanut Allergy Trial and Reports Positive Phase 3 Results DBV Technologies has started screening the first infant for its THRIVE Phase 2 trial, testing the Viaskin Peanut patch in children aged 6 to 12 months with peanut allergy over a 36‑month treatment period followed by a food challenge.
The company reported positive Phase 3 VITESSE results in older children, which coincided with a roughly 2% rebound in the stock after it had tested technical support around €2.75.
DBV plans to present the THRIVE study protocol at the 2026 European Academy of Allergy and Clinical Immunology Congress, and CEO Daniel Tassé recently highlighted both THRIVE and VITESSE at the Goldman Sachs Global Healthcare Conference.
These updates point to a company leaning on a maturing clinical program in peanut allergy across multiple pediatric age groups, with both late‑stage data and earlier‑stage expansion into infants now in motion.
For you, the key question is whether DBV can convert these clinical milestones and conference visibility into regulatory progress, reimbursement traction and, eventually, commercial uptake if approvals are secured. 
