DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe

Core Insights - DBV Technologies announced positive regulatory updates for the Viaskin Peanut patch in the U.S. and Europe, including an Accelerated Approval pathway for toddlers aged 1-3 years [1][2][9] - The company plans to initiate a six-month supplemental safety study in toddlers in Q2 2025, which is a prerequisite for the Biologics License Application (BLA) submission [1][4] - The VITESSE Phase 3 study for children aged 4-7 years exceeded enrollment goals, with topline results expected in Q4 2025 [1][8] Regulatory Developments - DBV has received FDA guidance confirming that the Viaskin Peanut patch meets the criteria for Accelerated Approval, addressing a serious condition with meaningful advantages over existing therapies [2][3] - The European Medicines Agency (EMA) has provided scientific advice confirming a registration path for a Marketing Authorization Application (MAA) for the modified patch for ages 1-7 [1][9] Clinical Studies - The COMFORT Toddlers safety study will enroll approximately 300-350 subjects, aiming to build a safety database of around 600 subjects for toddlers [4] - The VITESSE study for children aged 4-7 years enrolled 654 subjects, with plans for a safety study to begin in Q2 2025 [8] Financial Overview - As of September 30, 2024, DBV reported cash and cash equivalents of $46.4 million, down from$66.2 million as of June 30, 2024, primarily due to operating expenses [11] - The company anticipates that its cash reserves will support operations into Q1 2025, with plans to seek additional capital for ongoing research and development [13] Investor Engagement - DBV management will host an investor conference call to discuss these regulatory updates, scheduled for October 22, 2024, at 5:00 PM ET [14]