DBV Now Plans BLA Submission For Viaskin Peanut Patch In Children 4 - 7-years-old In H1, 2026

(RTTNews) - DBV Technologies announced that in a Written Responses to the Type D IND meeting request, the FDA agreed with the company's proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 - 7-year-olds will be sufficient to support a Biologics License Application filing in this age group. The COMFORT Children supplemental safety study will no longer be required, which accelerates the timeline for a BLA submission of Viaskin peanut patch in 4 - 7-year-olds with a peanut allergy. The company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year.

"DBV is commencing preparations for a BLA submission in the first half of 2026 to be supported by the Phase 3 VITESSE study, which is on-track for readout of topline results in the fourth quarter of 2025," said Daniel Tassé, CEO, DBV Technologies.

DBV Technologies recorded a net loss of $113.9 million for the year ended December 31, 2024, compared to a net loss of $72.7 million for the year ended December 31, 2023. On a per share basis, net loss was $1.17 compared to a loss of $0.76. Operating income amounted to $4.2 million compared with $15.7 million, last year. Cash and cash equivalents amounted to $32.5 million as of December 31, 2024.

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