DBV Technologies S.A.

DBV Technologies has submitted a Biologics License Application to the U.S. Food and Drug Administration for the VIASKIN Peanut Patch in children with peanut allergy aged 4 through 7 years. The company has requested Priority Review of the application, and the FDA previously granted Breakthrough Therapy Designation to the patch. The submission is supported by positive results from the Phase 3 VITESSE trial, which enrolled 654 children and is the largest immunotherapy clinical trial to date for this population. VITESSE was conducted at 86 sites across the United States, Canada, United Kingdom, Europe, and Australia, with participants randomized 2:1 to receive the VIASKIN Peanut Patch or placebo. Chief Executive Officer Daniel Tassé called the submission a significant milestone in DBV's transformation into a commercial organization.

The food allergy market across the seven major markets was valued at approximately USD 2.7 billion in 2025 and is projected to expand at a robust CAGR of 9.4% through 2036, according to DelveInsight. The seven major markets comprise the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Key approved therapies include peanut allergen powder (PALFORZIA), omalizumab (XOLAIR), and epinephrine nasal spray (NEFFY). The pipeline features several emerging therapies, including DBV Technologies' Viaskin Peanut Patch in Phase III, Novartis' remibrutinib in Phase II, Aravax's PVX108 in Phase II, GSK's ozureprubart in Phase II, and Aquestive Therapeutics' epinephrine sublingual film ANAPHYLM in Phase III. GSK strengthened its position through the acquisition of RAPT Therapeutics, gaining access to ozureprubart.