DBVT DBV Technologies

DBV Technologies delays VIASKIN Peanut Patch BLA to Q3 2026

DBV will now file its BLA for the VIASKIN Peanut Patch in children 4-7 years old in Q3 2026 instead of an earlier timeline. The delay follows extensive pre-submission dialogue with the FDA to optimize CMC and biostatistical data organization. FDA has not requested any additional clinical data.

DBV Technologies delays VIASKIN Peanut Patch BLA to Q3 2026

DBV Technologies now plans to submit its BLA for the VIASKIN Peanut Patch in children aged 4-7 years in Q3 2026 rather than an earlier timeline. The company received FDA feedback on CMC and biostatistical data formatting and organization but no request for additional data. The delay is intended to incorporate this feedback to optimize the review process.

DBV Technologies delays VIASKIN Peanut BLA filing to Q3 2026

DBV Technologies has postponed its planned BLA submission for VIASKIN Peanut in children aged 4-7 years from an earlier timeline to Q3 2026. The company received FDA feedback on CMC and biostatistical data formatting and organization but no request for additional data. DBV will incorporate these comments before filing.

DBV Technologies presents VITESSE subgroup data and THRIVE protocol at EAACI 2026

DBV will present positive VITESSE Phase 3 subgroup data showing statistically significant response rates in peanut-allergic children with atopic comorbidities at the EAACI 2026 congress. The company will also unveil the protocol for its newly initiated Phase 2 THRIVE study evaluating VIASKIN Peanut in 6-12 month-old infants.

DBV Technologies plans VIASKIN Peanut Patch BLA filing H1 2026

The press release confirms the company is on track to submit a BLA for the VIASKIN Peanut Patch in children aged 4-7 years in the first half of 2026, following FDA alignment on safety data requirements and positive Phase 3 results. Cash runway extends into Q2 2027 after PIPE financing, supporting commercial readiness activities. A separate BLA for toddlers (ages 1-3) is guided for the second half of 2026.

DBV Technologies: BLA submission for VIASKIN Peanut Patch (4-7 yrs) planned H1 2026

The 8-K states that the Phase 3 VITESSE topline results were positive and that the company now anticipates submitting a BLA for the VIASKIN Peanut Patch in peanut-allergic children aged 4-7 years in the first half of 2026, with potential for Priority Review. A second BLA submission for toddlers aged 1-3 years is guided for the second half of 2026 under an Accelerated Approval Pathway. These planned filings represent the next concrete regulatory milestones for the asset.

DBV Technologies: VITESSE Phase 3 VIASKIN Peanut Patch meets primary endpoint

The VITESSE Phase 3 trial met its primary endpoint with a statistically significant treatment effect (p<0.001) showing 46.6% responders vs 14.8% placebo. Additional data presented at AAAAI 2026 demonstrate consistent desensitization across baseline eliciting dose strata and confirm the robustness of the primary analysis. The company plans to submit a BLA to FDA in the first half of this year.