DBV Technologies screens first subject in Phase 3 COMFORT Toddlers study for Viaskin Peanut

DBV Technologies S.A.

First subject screened at Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein as PI.
Study to enroll ~480 subjects at 80-90 centers across U.S., Canada, Australia, UK, and Europe.
BLA submission to FDA anticipated in 2H 2026 under Accelerated Approval Pathway.
Study supplements safety data from Phase 3 EPITOPE; 6-month DBPC phase + optional 18-month open-label.

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