DBV Technologies Anticipates Regulatory Progress with the FDA

DBV Technologies announced a significant agreement with the FDA regarding the Viaskin Peanut patch for children 4 to 7 years of age. Safety data from the VITESSE and OLE studies will be sufficient to file a BLA in the first half of 2026, without requiring the originally planned COMFORT study. This decision could accelerate commercialization by one year.

Preliminary results from the VITESSE study are expected by the end of 2025, an important step toward patch approval. Financially, DBV's cash position is down significantly to $32.5 million at the end of 2024, highlighting an urgent need for financing.

The company is continuing its research to secure the necessary funding and is considering marketing the patch, if approved, to relieve children with peanut allergies.