DBV Technologies Inc.

DBV Technologies progresses in regulatory efforts for Viaskin Peanut patch, aligning with FDA under Accelerated Approval Program for toddlers. Plans include COMFORT Toddlers safety study and Phase 3 VITESSE trial for older children. Addresses adhesion issues and seeks additional funding amid financial concerns.

DBV Technologies advances Viaskin Peanut patch with US FDA's Accelerated Approval for toddlers aged 1-3, starting a supplementary safety study in Q2 2025. The EMA supports a registration path for children aged 1-7. The Phase 3 VITESSE study for children aged 4-7 exceeded enrollment targets, with results expected by Q4 2025. DBV faces financial challenges, with cash only lasting until early 2025, necessitating additional capital.

DBV Technologies announces positive regulatory updates for Viaskin Peanut patch in the US and Europe, including pursuing Accelerated Approval for toddlers and EMA's confirmation of a 1-7 year-old indication path.

DBV announces positive regulatory updates for Viaskin Peanut patch in US & EU, pursuing Accelerated Approval for toddlers, with VITESSE Phase 3 study exceeding goals & EMA confirming registration path for 1-7 year-olds.

DBV Technologies announces positive regulatory updates for Viaskin Peanut patch in the U.S. and Europe, including pursuing Accelerated Approval for toddlers ages 1-3 and EMA's confirmation of a 1-7 year-old indication path.

DBV Technologies completed screening for the VITESSE Phase 3 trial, evaluating the Viaskin Peanut Patch in peanut-allergic children ages 4-7, with topline results expected by Q4 2025.