DBV TECHNOLOGIES SA · Data as of 2026-09-08
Q3 2026
Continued productive engagement with the FDA in support of the BLA for the VIASKIN ® Peanut Patch in children aged 4 through 7 years, with submission of the BLA anticipated in the third quarter of 2026Source filing
H2 2026
Conditional on successful completion of this safety study, the Company is planning for a BLA submission in the second half of 2026 for children ages one to three.Source filing
Q3 2026
DBV is incorporating valuable, actionable feedback from the FDA specific to the organization, mapping and formatting of existing CMC and biostatistical data sets, and now anticipates submitting the BLA in the third quarter of 2026.Source filing
Q3 2026
The Company announced further that it will take the required time to incorporate the FDA's feedback and anticipates the BLA filing to occur in the third quarter of 2026.Source filing
in 2027
With a Phase IIb readout expected in 2027 and Phase 3 trials planned thereafter, ozureprubart could emerge as a competitor in segments characterized by persistent unmet needs.Source filing