DBVT - BLA Submission in Children Pushed to 3Q26; We Think This Modest Delay in BLA Submission Is an Opportunity to Reinforce Credibility With Regulators

Research evidence excerpt

DBVT - BLA Submission in Children Pushed to 3Q26; We Think This Modest Delay in BLA Submission Is an Opportunity to Reinforce Credibility With Regulators

FLASH NOTE

June 30, 2026

Yatin Suneja yatin.suneja@guggenheimpartners.com DBVT - BLA Submission in Children Pushed to 3Q26;

212 518 9565 We Think This Modest Delay in BLA Submission Is an

Min Lee, Ph.D.

min.lee@guggenheimpartners.com Opportunity to Reinforce Credibility With Regulators

212 823 6744

Iris Gao, Ph.D. Key Message: Yesterday, DBVT provided an update regarding the BLA submission of

iris.gao@guggenheimpartners.com VIASKIN peanut patch in children (Ages 4-7 YO). In short, the BLA submission timeline 212 518 9013

has been slightly pushed back to 3Q26. While we acknowledge that some investors

Eddie Hickman, Ph.D. are understandingly disappointed by this postponement, we would like to highlight that

eddie.hickman@guggenheimpartners.com the delay is primarily attributable to the organization, mapping, & formatting of existing

212 518 9904 datasets for the CMC and biostatistical elements of the BLA package - No additional

Delma Caiati, M.D., Ph.D. data nor new content analysis was requested by the FDA. Per our conversation

delma.caiati@guggenheimpartners.com with mgmt, the FDA has directly reached out to DBVT that the filing package was

617 859 4606 comprehensive and well in-line with what regulators would like to see. Given the highly

sophisticated nature of VIASKIN's epicutaneous immunotherapy platform (one of the

largest review package after Palforzia), we think this modest delay is a necessary hurdle

DBVT topeanutreinforceallergyDBVT'sand theiralignmentparentswitharetheveryFDA.vocalTheregardingFDA is well-awaretheir experiencethat bothwithchildrenVIASKINwith

DBV Technologies S.A.