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

ChÂtillon, france, march 24, 2025 dbv technologies secures agreement with fda on safety exposure data required for biologics license application (bla) for viaskin® peanut patch in 4 – 7-year-olds, accelerating the timeline for a bla filing submission to 1h 2026, and reports 2024 unaudited financial results 1 comfort children supplemental safety study in children 4 – 7-years-old no longer required fda confirms safety exposure data generated from vitesse phase 3 clinical study and vitesse open-label extension (ole) are sufficient to support a biologics license application (bla) for viaskin peanut patch in children 4 – 7-years-old vitesse topline results on-track for the fourth quarter of 2025 bla submission for viaskin peanut patch in children 4 – 7-years-old is now expected in the first half of 2026; dbv anticipates this path may accelerate potential launch, if approved by the fda, by approximately one year dbv also reports unaudited financial results 1 for the full year 2024, including cash and cash equivalents dbv technologies (euronext: dbv – isin: fr0010417345 – nasdaq stock market: dbvt, the “company”), a clinical-stage biopharmaceutical company, today announced that in a written responses only to the company's type d ind meeting request, the u.s. food and drug administration (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 (bla) filing in this age group. as a result, 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.
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