Core Viewpoint - DBV Technologies has initiated the COMFORT Toddlers supplemental safety study for the Viaskin® Peanut patch, targeting peanut-allergic children aged 1 to 3 years, marking a significant step towards advancing this treatment option to market [1][3][4]. Group 1: Study Details - The COMFORT Toddlers study aims to enroll approximately 480 subjects across 80 to 90 study centers in the U.S., Canada, Australia, the UK, and Europe [2]. - The study is a Phase 3 double-blind, placebo-controlled safety trial designed to supplement safety and efficacy data from the completed Phase 3 EPITOPE study [3]. - The study duration is six months, followed by an optional 18-month open-label treatment phase, allowing for up to 24 months of active treatment for participants in the active group [3]. Group 2: Investigator Insights - Dr. Jeffrey Leflein, the Principal Investigator, expressed enthusiasm about the first subject being screened and highlighted the commitment to peanut-allergic children and their families [3]. - Dr. Julie Wang, Global Principal Investigator, noted the significant unmet need for this specific cohort, emphasizing the importance of the study [4]. - CEO Daniel Tassé stated that the data from this study will be crucial for a Biologics License Application (BLA) submission to the FDA, anticipated in the second half of 2026 [4]. Group 3: Company Background - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies, particularly through its proprietary Viaskin® patch technology [9]. - The company aims to address food allergies, which affect millions, including young children, by utilizing epicutaneous immunotherapy (EPIT™) to desensitize the immune system [9]. - DBV is committed to transforming the care of food-allergic individuals and is currently conducting clinical trials for the Viaskin Peanut patch in both toddlers and children [9].

Core Viewpoint - DBV Technologies has initiated the COMFORT Toddlers supplemental safety study for the Viaskin® Peanut patch, targeting peanut-allergic children aged 1 to 3 years, marking a significant step towards advancing this treatment option to market [1][3][4]. Group 1: Study Details - The COMFORT Toddlers study aims to enroll approximately 480 subjects across 80 to 90 study centers in the U.S., Canada, Australia, the UK, and Europe [2]. - The study is a Phase 3 double-blind, placebo-controlled safety trial designed to supplement safety and efficacy data from the completed Phase 3 EPITOPE study [3]. - The study duration is six months, followed by an optional 18-month open-label treatment phase, allowing for up to 24 months of active treatment for participants in the active group [3]. Group 2: Investigator Insights - Dr. Jeffrey Leflein, the Principal Investigator, expressed enthusiasm about the first subject being screened and highlighted the commitment to peanut-allergic children and their families [3][4]. - Julie Wang, Global Principal Investigator, noted the significant unmet need for this specific cohort, reinforcing the importance of the study [4]. Group 3: Regulatory and Future Plans - The data generated from the COMFORT Toddlers study is expected to support a Biologics License Application (BLA) submission to the FDA, anticipated in the second half of 2026 under the Accelerated Approval Pathway [4]. - The company is focused on advancing the development of the Viaskin Peanut patch, which aims to address food allergies through epicutaneous immunotherapy [9].

Core Points - DBV Technologies will hold its Combined General Meeting on June 11, 2025, at 02:00 p.m. CEST at its headquarters in Châtillon, France [1] - The preliminary notice with the detailed agenda and instructions for participation was published on May 07, 2025 [2] - Shareholders can access preparatory documents on the Company's website, in compliance with legal provisions [3] - Shareholders wishing to receive documents by post or electronically must request them by June 06, 2025 [4] - A live webcast of the General Meeting will be available on the Company's website, with a recorded version accessible for at least the minimum legal period [5] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions [6] - The Company utilizes its proprietary Viaskin technology platform to address food allergies through epicutaneous immunotherapy (EPIT™) [6] - DBV Technologies is conducting clinical trials for Viaskin Peanut in peanut allergic toddlers and children [6] - The Company is headquartered in Châtillon, France, with operations in Warren, NJ, and its shares are traded on Euronext Paris and Nasdaq [7]

Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions with significant unmet medical needs [6] - The company is investigating the use of its proprietary technology platform, Viaskin, to address food allergies through epicutaneous immunotherapy (EPIT™) [6] - DBV Technologies is committed to transforming the care of individuals with food allergies, with ongoing clinical trials for Viaskin Peanut targeting peanut allergic toddlers and children [6] Upcoming General Meeting - The Combined General Meeting is scheduled for June 11, 2025, at 02:00 p.m. CEST at the company's headquarters in Châtillon, France [1] - A preliminary notice containing the detailed agenda and draft resolutions was published on May 07, 2025, and the official meeting notice will be published on May 21, 2025 [2] - Shareholders can access preparatory documents on the company's website, and requests for documents can be made until June 06, 2025 [3][4] Webcast Information - A live webcast of the General Meeting will be available on the company's website, with a recorded version accessible within seven business days after the meeting [5]