DBV Technologies reports Q3 EPS (17c), consensus (24c)

Reports Q3 revenue $2.4M, consensus $1.31M.Following DBV’s request for clarification after receipt of Type C Meeting feedback in July 2023, the FDA provided Written Responses on protocol design elements for the COMFORT supplemental safety studies. Both COMFORT Toddlers and COMFORT Children protocol will have harmonized language guiding how the product will be used in the trials, such as, “Each DBV712 250 microgram epicutaneous system is intended to be worn for a full day .” These instructions are simpler and more concise relative to previously used protocol language. Further to this approach, both supplemental safety studies will seek to enroll populations that are closely aligned with their respective Phase 3 efficacy studies, as is feasible. For COMFORT Toddlers, eligibility criteria will be the same as in EPITOPE as reliance on peanut specific-IgE and skin prick test alone does not ensure a Regulatory-level of assurance of peanut allergy or a similar peanut allergic patient population relative to EPITOPE. Thus, COMFORT Toddlers will include a double-blind, placebo-controlled food challenge as part of the Inclusion criteria.