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 Viewpoint - DBV Technologies will participate in the EAACI Congress 2025, presenting new data on its VIASKIN® peanut patch and hosting a symposium focused on peanut allergy research [1][3][4] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions, utilizing its proprietary VIASKIN® patch technology [7][8] - The company aims to address food allergies through epicutaneous immunotherapy (EPIT™), which introduces microgram amounts of allergens to the immune system via the skin [7] Upcoming Presentations - At the EAACI Congress, DBV will present data from the EPITOPE open-label extension trial, highlighting reduced rates of reactions from accidental peanut consumption with the VIASKIN® peanut patch [2][4] - The APTITUDE study results will also be shared, evaluating the sensitivity, specificity, and safety of the VIASKIN® patch for diagnosing non-IgE mediated cow's milk allergy in infants [2][4] Symposium Details - The symposium titled "Peanut Allergy: Recent Research Highlights" will be co-chaired by Prof Gideon Lack and Prof Alexandra Santos, featuring discussions on the clinical relationship between allergists and food-allergic patients [3][5] - Presentations will include insights on epicutaneous immunotherapy and new clinical data related to peanut allergy [6][7] Clinical Data Highlights - Year 2 data from the EPITOPE trial will demonstrate real-world protective effects of the VIASKIN® peanut patch in peanut-allergic toddlers, showing further reductions in accidental peanut consumption-related reactions [4][7] - The APTITUDE study, despite early termination due to enrollment challenges, is viewed as a positive step in demonstrating the potential of the VIASKIN® patch in food allergy management [4][7]

Core Insights - DBV Technologies held its Combined General Meeting where shareholders approved all proposed resolutions [1][2] 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 [3] - The company is investigating its proprietary technology platform, Viaskin™, which aims to address food allergies through epicutaneous immunotherapy (EPIT™) [3] - Viaskin is designed to introduce microgram amounts of biologically active compounds to the immune system via intact skin, aiming to modify the underlying allergy by re-educating the immune system [3] - The company is committed to transforming the care of individuals with food allergies, with ongoing clinical trials for Viaskin Peanut targeting peanut allergic toddlers and children [3] Operations and Trading - DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ [4] - The company's ordinary shares are traded on segment B of Euronext Paris and its American Depositary Shares (ADSs) are traded on the Nasdaq Capital Market [4]

Core Points - DBV Technologies has filed an addendum to the 2024 Universal Registration Document with the French market authority AMF [1] - The addendum updates the Corporate Governance Report regarding exceptional compensation granted to the CEO, pending approval at the Annual Combined General Meeting on June 11, 2025 [2] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions with significant unmet medical needs [4] - The company utilizes its proprietary Viaskin technology platform to address food allergies through epicutaneous immunotherapy (EPIT™), which aims to desensitize the immune system to allergens [4] - Ongoing clinical trials include Viaskin Peanut for peanut allergic toddlers and children [4] Operations and Trading - DBV Technologies is headquartered in Châtillon, France, with operations in Warren, NJ, North America [5] - The company's ordinary shares are traded on Euronext Paris and its American Depositary Shares (ADSs) on the Nasdaq Capital Market [5]

Company Overview - DBV Technologies S.A. (DBVT) is a notable stock within the Medical sector, which consists of 999 companies and currently ranks 4 in the Zacks Sector Rank [2] - The company is categorized under the Medical - Biomedical and Genetics industry, which includes 506 stocks and is ranked 70 in the Zacks Industry Rank [6] Performance Metrics - DBVT has experienced a year-to-date gain of approximately 210.7%, significantly outperforming the average loss of 4.4% in the Medical sector [4] - The Zacks Consensus Estimate for DBVT's full-year earnings has increased by 78.9% over the past quarter, indicating a positive shift in analyst sentiment [4] Comparison with Peers - Hims & Hers Health, Inc. (HIMS) is another Medical stock that has shown strong performance, with a year-to-date return of 153.1% and a Zacks Rank of 2 (Buy) [5] - The Medical Info Systems industry, to which HIMS belongs, has seen a year-to-date increase of 16.9%, contrasting with the performance of DBVT's industry [7]

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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]

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 [3][4] - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ [4] Technology and Treatment Approach - DBV Technologies is investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by hypersensitive immune reactions [3] - The VIASKIN® patch is designed to introduce microgram amounts of biologically active compounds to the immune system through intact skin, utilizing epicutaneous immunotherapy (EPIT™) [3] - EPIT™ aims to modify an individual's underlying allergy by re-educating the immune system to become desensitized to allergens, leveraging the skin's immune tolerizing properties [3] Clinical Trials and Focus Areas - The company is currently conducting ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (ages 1 to 3) and children (ages 4 to 7) [3]