DBV gets FDA Accelerated Approval path for Viaskin Peanut patch in toddlers; cash $46.4M, going concern doubt

DBV Technologies S.A.

FDA confirmed Accelerated Approval pathway for Viaskin Peanut patch in 1-3 year-olds; COMFORT safety study (n=300-350) to start Q2 2025.
VITESSE Phase 3 study in 4-7 year-olds enrolled 654 subjects; topline results expected Q4 2025.
EMA scientific advice confirms MAA path for 1-7 year-old indication in Europe using the modified patch.
Preliminary cash at Sep 30, 2024: $46.4M (down from $66.2M); Q3 net cash burn $19.8M.
Substantial doubt about going concern; cash expected to fund operations only into Q1 2025; additional capital needed.

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