DBV Technologies Advances Viaskin Peanut Patch with FDA

DBV Technologies S.A. – American Depositary Shares ( (DBVT) ) has released its Q4 earnings. Here is a breakdown of the information DBV Technologies S.A. – American Depositary Shares presented to its investors.

DBV Technologies S.A. is a clinical-stage biopharmaceutical company specializing in innovative treatment options for food allergies, utilizing its proprietary VIASKIN® patch technology. The company recently announced a significant milestone with the U.S. FDA regarding its Viaskin Peanut Patch for children aged 4-7, which could expedite the product’s market launch.

The FDA has agreed that the safety exposure data from the VITESSE Phase 3 study is sufficient for a Biologics License Application (BLA), eliminating the need for an additional safety study. This decision accelerates the timeline for a BLA submission to the first half of 2026, potentially bringing the Viaskin Peanut Patch to market a year earlier than anticipated.

Financially, DBV Technologies reported a net loss of $113.9 million for 2024, with cash and cash equivalents dropping to $32.5 million by year-end, highlighting the company’s need for additional funding to continue its operations and research activities. The increase in operating expenses, primarily due to research and development costs, underscores the company’s commitment to advancing its clinical trials.

Looking ahead, DBV Technologies is preparing for a BLA submission for the Viaskin Peanut Patch, with the VITESSE study’s topline results expected in late 2025. The company remains focused on securing necessary financing to support its strategic objectives and bring its innovative allergy treatment to market, pending FDA approval.