DBV Technologies (DBV) Status Update summary

Regulatory milestones and FDA/EMA guidance

• FDA agreed to an accelerated approval pathway for the VIASKIN Peanut patch in toddlers aged 1–3, requiring a six-month safety study (COMFORT Toddlers) to start in Q2 2025, with patch adhesion no longer a study objective.

• Accelerated approval is based on EPITOPE Phase 3 efficacy data and will require a post-marketing confirmatory study to confirm clinical benefit.

• The regulatory path for the 4–7 year-old program is separate, with its own BLA and studies, including the VITESSE Phase 3 study.

• EMA confirmed a registration path for a Marketing Authorization Application for a 1–7 year-old indication, contingent on positive VITESSE results and a new toddler safety study.

• Recent European guidelines recommend epicutaneous immunotherapy for peanut allergy, supporting the potential of VIASKIN Peanut.

Clinical development and study updates

• The VITESSE Phase 3 study in children aged 4–7 is fully enrolled with 654 subjects, exceeding initial targets; topline results are expected in Q4 2025.

• COMFORT Toddlers safety study will enroll 300–350 subjects, bringing the toddler safety database to about 600.

• COMFORT Children safety study for ages 4–7 will enroll about 250 subjects and is planned to start in Q2 2025, running in parallel with the toddler study.

• Each age group will have a distinct BLA, supported by efficacy, safety, and open-label extension studies.

• Confirmatory effectiveness study will be initiated at BLA submission and run in parallel with commercialization if approved.

European regulatory and market landscape

• EMA supports a single patch for 1–7 year-olds, contingent on positive data from both age groups and a new toddler safety study.

• There is a significant unmet need in Europe, with over 600,000 children affected by peanut allergies.

• Viaskin Peanut patch aims to address this unmet need, with support from patient advocacy groups.