DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results

Core Insights - DBV Technologies has secured an agreement with the FDA regarding the safety exposure data required for the Biologics License Application (BLA) for the Viaskin® Peanut Patch in children aged 4 to 7 years, which accelerates the timeline for submission to the first half of 2026 [1][2][5] - The company reported unaudited financial results for the full year 2024, indicating significant cash consumption and operating losses [8][11][12] FDA Agreement and Clinical Trials - The FDA has agreed that the safety data from the VITESSE Phase 3 study will be sufficient for the BLA, eliminating the need for the COMFORT Children supplemental safety study [2][5][6] - The VITESSE study is the largest Phase 3 clinical trial for peanut allergy in this age group, enrolling 654 participants, and is expected to provide robust safety data [3][4][5] - The BLA submission is now anticipated in the first half of 2026, potentially accelerating the product launch by approximately one year, pending FDA approval [2][5][6] Financial Results - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from$141.4 million at the end of 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial expenses [11][12][15] - Operating income for 2024 was$4.2 million, down from $15.7 million in 2023, attributed to the termination of a collaboration agreement and a lower Research Tax Credit [16][22] - The company recorded a net loss of$113.9 million for 2024, compared to a net loss of $72.7 million in 2023, with a net loss per share of$(1.17) [22][23][26] Research and Development - Operating expenses rose to $120.7 million in 2024, up from$92.2 million in 2023, driven by increased research and development costs related to the ongoing VITESSE trial and preparatory activities for supplemental safety studies [18][21][26] - The company plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers aged 1 to 3 years, with a BLA submission expected in the second half of 2026 [6][29]