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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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.