DBV gets FDA path for Viaskin Peanut BLA in toddlers 1-3; EPITOPE efficacy confirmed

DBV Technologies S.A.

FDA confirmed Phase 3 EPITOPE met primary endpoint; no additional efficacy study required.
FDA requires new safety study in ~600 toddlers to augment safety data; no food challenge needed.
Company to submit safety study protocol to FDA by end of Q2 2023; Human Factors study and CMC work ongoing.
Cash and cash equivalents $192.3M as of March 31, 2023 (down $16.9M from Dec 31, 2022).
Viaskin Peanut in 1-3 and 4-7 year-olds remain separate product candidates with independent paths.

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