DBV Technologies S.A. announced plans to initiate a new, pivotal Phase 3 clinical study for a modified Viaskin Peanut patch in children in the intended patient population. The Company also issued an update on the Marketing Authorization Application for Viaskin Peanut with the European Medicines Agency. DBV has informed the U.S. Food and Drug Administration of its intent to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch in children in the intended patient population. The study will feature the modified Viaskin Peanut patch, which is circular in shape and approximately 50% larger than the current Viaskin Peanut patch. The mVP outperformed cVP in the healthy adult CHAMP study. The new pivotal study will also include updates to the Instructions for Use. DBV received advice and information requests from the FDA concerning the allergen uptake/transport comparability of the mVP to the cVP at the end of November 2021. In review of this communication, it is clear that additional exchanges with the FDA would be needed before DBV could initiate an allergen uptake comparison of mVP and cVP. As previously disclosed, the FDA informed DBV in October 2021 that it would provide additional comments on the STAMP protocol design only after reviewing the data from the allergen uptake/transport comparability study. After careful review of the FDA’s information requests and consideration of all other options, the Company has decided not to pursue the sequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 feedback. DBV had planned to run these studies in parallel. DBV estimates that heeding to FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, a 6-month safety and adhesion study. DBV does not believe this approach to be in the best interest of patients due to the significant time delays associated with FDA review of a resource dependent product. As such, DBV believes the most efficient way to progress the regulatory pathway for Viaskin Peanut is to conduct a new, Phase 3 placebo-controlled efficacy trial similar to PEPITES. DBV considers this approach the most straightforward to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA has confirmed DBV’s change in strategy is agreeable via oral and written exchanges. DBV has begun working on a study protocol for the Phase 3 placebo-controlled efficacy trial with mVP and will gain alignment from FDA before initiating the trial. The Company is in the process of finalizing the new, pivotal Phase 3 protocol and expects to submit the protocol to FDA by the end of February 2022. DBV Technologies announced that it has formally notified the European Medicines Agency of its decision to withdraw the Marketing Authorization Application for Viaskin Peanut. The application for Viaskin Peanut was accepted by the EMA in November 2020. At the time of the withdrawal, it was under review by the EMA’s Committee for Medicinal Products for Human Use. The initial filing was supported by positive data from a single, Phase 3 pivotal trial, PEPITES. The decision to withdraw was based on the current view of the CHMP that the data available to date from a single pivotal study in the MAA were not sufficient to preclude a Major Objection at Day 180 of the review process. As previously disclosed, the Major Objection focuses on the limitations of the data, for example, the clinical relevance and effect size. DBV believes that generating data from a new, Phase 3 pivotal trial will support a more robust path to licensure for Viaskin Peanut in the European Union.