DBV Technologies Inc.

DBV Technologies aligns with FDA on Accelerated Approval for Viaskin Peanut patch in toddlers 1-3 years old, with COMFORT Toddlers study to start in 2Q 2025 and BLA submission anticipated in 2H 2026. FDA confirms post-marketing confirmatory study criteria and DBV focuses on executing studies for BLA submissions across age groups.

DBV Technologies confirms alignment with FDA on Accelerated Approval for Viaskin Peanut patch in toddlers 1-3 years-old. COMFORT Toddlers study to start in 2Q 2025, with BLA submission anticipated in 2H 2026. FDA confirmed criteria for post-marketing confirmatory study.

DBV Technologies secures FDA alignment on Accelerated Approval for Viaskin® Peanut patch in toddlers aged 1-3 years, using Phase 3 EPITOPE study data as an intermediate clinical endpoint. The COMFORT Toddlers study, set to begin in Q2 2025, will enroll 480 subjects across multiple countries. DBV plans to submit a Biologics License Application (BLA) in 2H 2026, with a post-marketing confirmatory study required at BLA submission.

DBV Technologies aligns with U.S. FDA on Accelerated Approval for Viaskin® Peanut Patch in toddlers 1-3 years, focusing on study design and post-marketing confirmatory study. COMFORT Toddlers study to start in 2Q 2025, with BLA submission expected in 2H 2026. FDA confirms criteria for approval, emphasizing safety and efficacy.

DBV Technologies shares rose 31% in after-hours trading following confirmation of FDA alignment on accelerated approval for its Viaskin Peanut Patch in children aged 1 to 3. The stock closed down 4.6% at $3.29. A biologics license application for the patch is expected in H2 2026.

DBV Technologies aligns with FDA on Accelerated Approval for Viaskin® Peanut Patch in toddlers 1-3 years, with COMFORT Toddlers study starting 2Q 2025 and BLA submission expected 2H 2026. FDA confirmed criteria for post-marketing study, emphasizing safety and efficacy data collection.

DBV Technologies announced a clear regulatory pathway for Viaskin Peanut patch in toddlers 1-3 years old, with FDA guidance on Accelerated Approval. Key design elements for a post-marketing confirmatory study were agreed upon. Modifications to the patch for commercialization were made, and a Phase 3 study, COMFORT Toddlers, will assess safety and adhesion. A BLA submission is anticipated in 2H 2026.

DBV Technologies progresses with Viaskin patch for peanut and milk allergies, aiming for FDA approval. Studies show promising results, with 81% of toddlers tolerating peanuts after 2 years. The patch, part of epicutaneous immunotherapy, may offer sustained unresponsiveness. DBV plans to expand treatment to cashew and potentially other allergens.

DBV Technologies reported a net loss of $90.9 million for the first nine months of 2024, up from $61.5 million in 2023, due to a 35% increase in operating expenses to $96.4 million, mainly from higher R&D costs. The company expects its $46.4 million cash balance to fund operations until Q1 2025.

DBV Technologies announced progress in its regulatory efforts for the Viaskin Peanut patch, aligning with the FDA under the Accelerated Approval Program for toddlers aged 1–3. DBV plans to begin enrolling subjects in the COMFORT Toddlers study in Q2 2025, with around 300–350 toddlers. The company also completed patient screening for the Phase 3 VITESSE trial in September 2024, enrolling 654 children aged 4–7 years, with topline data expected in Q4 2025. DBV received scientific advice from the European Medicines Agency for a broader age range of 1–7 years in Europe. Financial concerns remain as DBV anticipates its cash will fund operations only through Q1 2025, actively seeking new capital.