공시 • Jul 01
DBV Technologies Provides BLA Submission Update For The VIASKIN Peanut Patch In Children Aged 4 Through 7 Years DBV Technologies provided an update on the Biologics License Application (BLA) submission seeking marketing approval of the VIASKIN Peanut Patch in children aged four through seven years. Over recent weeks, DBV has had ongoing detailed and iterative engagement with the U.S. Food and Drug Administration (FDA) with the objective of ensuring a complete, efficient, and timely review of the Company’s upcoming BLA for children aged four through seven years. DBV and the FDA have collaborated through meetings, information exchanges, and filings for the VIASKIN Peanut Patch Investigational New Drug Application (IND). Through this process and based on its review, DBV received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The FDA has not requested additional data. The Company will take the required time to incorporate that feedback and now anticipates filing of the BLA to occur in the third quarter of 2026. The VIASKIN Peanut Patch is a novel and complex product with no regulatory precedent. Epicutaneous immunotherapy (EPIT), the VIASKIN Peanut Patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut Patch in toddlers (1 through 3 years of age) and children (4 through 7 years of age) with peanut allergy. 공시 • Jun 09
DBV Technologies Presents New Positive Data from VITESSE Study and Previews Recently Initiated THRIVE Study at EAACI Congress 2026 DBV Technologies announced new positive data from its Phase 3 VITESSE study of the VIASKIN Peanut Patch in children ages 4 through 7 years with peanut allergy, and a preview of the design of its Phase 2 THRIVE study in infants ages 6 through 12 months with peanut allergy. Both will be presented in oral abstract sessions at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, taking place June 12 – 15, 2026 in Istanbul, Turkey. In the Phase 3 VITESSE study, VIASKIN Peanut Patch demonstrated statistically significant efficacy vs. placebo in the subgroups of children with peanut allergy who also had another common atopic condition, including asthma, concomitant food allergy, or atopic dermatitis. DBV will also present the clinical trial design of its recently initiated THRIVE study, which will assess the efficacy and safety of the VIASKIN Peanut Patch in achieving ad lib consumption of peanuts in infants ages 6 through 12 months with peanut allergy following three years of treatment. This scientific presentation details a subgroup analysis of participants in the successful VITESSE Phase 3 study of the VIASKIN Peanut Patch in children ages 4 through 7 years with peanut allergy and another atopic comorbidity, including asthma, additional food allergies or atopic dermatitis. In the VITESSE study, 654 participants were randomized to receive the VIASKIN Peanut Patch (n=438) or placebo (n=216). Atopic comorbidities were highly prevalent; specifically, 35.8% (n=234) of participants had asthma, 56.6% (n=370) had additional food allergies, and 61.8% (n=404) had atopic dermatitis. At 12 months, significantly more participants treated with the VIASKIN Peanut Patch met the response criteria compared with those who received placebo across all concomitant atopic comorbidity subgroups. 공시 • Jun 03
DBV Technologies Screens First Participant In Thrive Phase 2 Study Of The Viaskin Peanut Patch In Infants With Peanut Allergy DBV Technologies announced that the first participant has been screened in the THRIVE Phase 2 clinical study evaluating the efficacy and safety of the VIASKIN Peanut Patch in achieving ad lib consumption of dietary peanut in infants ages 6 through 12 months in achieving ad lib consumption of dietary peanut. The study is evaluating the efficacy and safety of the VIASKIN Peanut Patch in achieving ad lib consumption of dietary peanut in infants ages 6 through 12 months with peanut allergy. THRIVE is a Phase 2, single-arm, open-label study to assess the efficacy and safety of the VIASKIN Peanut Patch in achieving ad lib consumption of dietary peanut in infants ages 6 through 12 months with peanut allergy. All participants will have the VIASKIN Peanut Patch applied daily for 36 months while maintaining a peanut-free diet. At 36-months, a peanut food challenge will be conducted to determine the peanut consumption regimen for the next 12-months (months 37-48 of the study). Depending on the results of the peanut food challenge, some participants will enter the 12-month peanut consumption period without further VIASKIN Peanut Patch treatment, while others will continue to wear the patch. “Ad lib” peanut consumption is defined in the protocol using prespecified criteria based on tolerated single-sitting intake, longitudinal consumption patterns, and caregiver-reported outcomes. Based on individual participant tolerability to peanut consumption, some participants may be considered to reach “ad lib” peanut consumption (i.e., consuming peanut as much and as often as desired) during the fourth year of the study. 공시 • May 01
DBV Technologies S.A., Annual General Meeting, Jun 03, 2026 DBV Technologies S.A., Annual General Meeting, Jun 03, 2026. Location: 107 avenue de la republique, chatillon France 공시 • Mar 02
Dbv Technologies Highlights Additional Data from Successful Phase 3 Vitesse Study At the Aaaai 2026 Annual Meeting DBV Technologies announced that the company shared additional positive data from the successful Phase 3 VITESSE clinical trial as an oral presentation at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2026 Annual Meeting, in Philadelphia, PA. VITESSE, the food allergy immunotherapy trial to date, is a Phase 3 study assessing DBV's VIASKIN®? Peanut Patch for the treatment of peanut-allergic children aged 4 to 7 years. The VITESSE study met its primary endpoint whereby VIASKIN®?Peanut demonstrated a statistically significant treatment effect (pp. The increases in eliciting dose seen are clinically meaningful and may reflect a reduced risk of an allergic reaction. Conversely, nearly four times as many children on placebo saw their eliciting dose decrease, becoming more sensitized over the twelve-month period. These results not only support the VIASKIN®? peanut Patch as a potential treatment option for peanut-allergic children, if approved, but also reinforce the importance of prioritizing a proactive treatment for this specific patient population. 공시 • Nov 04
DBV Technologies Appoints Industry Leader Kevin Trapp as Chief Commercial, Effective November 3, 2025 DBV Technologies announced the appointment of Kevin Trapp as Chief Commercial Officer, effective immediately. In his role, Mr. Trapp will report directly to Daniel Tasse, Chief Executive Officer, as a member of the executive team and will lead all aspects of global commercial strategy and execution for the Viaskin(R) Peanut patch. DBV expects to submit a Biologics License Application (BLA) submission for children 4-7 years-old living with peanut allergy in the first half of 2026, followed by an anticipated BLA submission for 1-3 year-olds in the second half of the year. Kevin Trapp is an accomplished commercial executive with more than 30 years of experience in the biopharmaceutical industry. Before rejoining DBV, Kevin served as a consultant to the Company in his most recent role as Managing Director at Biotech Value Advisors (BVA) where he advised biotechnology boards of directors and executive leadership with product strategy, launch planning, and business evaluation. He built his career at Bristol-Myers Squibb (BMS), where he held roles of increasing responsibility across finance, sales, marketing, and general management. During his time at BMS, he managed a ~$4 billion U.S. specialty and primary care portfolio and was a key stakeholder in the planning and subsequent launches of more than 10 products and indications - including Abilify(R), Atripla(R), Reyataz(R), Orencia(R), and Daklinza(R). Mr. Trapp earned a bachelor's degree from the University of Connecticut School of Business and completed the General Management Program from the European Centre for Executive Development (CEDEP) at INSEAD. 공시 • Sep 19
DBV Technologies Announces Resignation of Daniel Soland as a Member of its Board of Directors, Effective September 18, 2025 DBV Technologies announced the resignation of Daniel Soland, as a member of its Board of Directors, effective September 18, 2025. 공시 • Sep 06
DBV Technologies S.A. has filed a Follow-on Equity Offering in the amount of $150 million. DBV Technologies S.A. has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Transaction Features: At the Market Offering 공시 • Jul 23
DBV Technologies S.A. Announces Executive Changes DBV Technologies S.A. announced the appointment of James Briggs as its Chief Human Resources Officer, succeeding Caroline Daniere. An experienced human capital executive, James will lead key initiatives as DBV transitions from a development-stage biotechnology company to a potential commercial organization. Mr. Briggs will report directly to Daniel Tassé, Chief Executive Officer, and serve as a member of the Executive Committee. Most recently, Mr. Briggs served as Partner at East Bay Human Capital, a human resources consulting firm specializing in human capital strategy, change management, and organizational design. Previously, he held several executive roles, including Chief Executive Officer at MNG Health, where he led the successful turnaround and sale of the healthcare technology company. He also served as Chief Human Resources Officer at multiple organizations, including Ciox Health and Ikaria Inc. Mr. Briggs holds a Master's degree in Human Relations and a Bachelor's degree in Communications from the University of Illinois at Urbana-Champaign. He is a certified Senior Professional in Human Resources (SPHR) and a Six Sigma Green Belt. 공시 • Jun 26
DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 - 3 Years Old DBV Technologies provided an update on the progress on the Company's COMFORT Toddlers supplemental safety study using the Viaskin®? Peanut patch 250 mg in peanut-allergic children ages 1 - 3 years old. COMFORT Toddlers will enroll approximately 480 subjects at approximately 80 - 90 study centers across the U.S., Canada, Australia, UK and Europe. COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) safety study designed to supplement the safety and efficacy data from the completed Phase 3 EPITOPE study in the same population. The study duration will be six months followed by an optional 18-month open-label treatment phase, to generate up to 24 or 18 months of active treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. 공시 • May 06
DBV Technologies S.A., Annual General Meeting, Jun 11, 2025 DBV Technologies S.A., Annual General Meeting, Jun 11, 2025. Location: 107 avenue de la republique 92320 chatillon, France 공시 • Apr 01
DBV Technologies S.A. announced delayed annual 10-K filing On 03/31/2025, DBV Technologies S.A. announced that they will be unable to file their next 10-K by the deadline required by the SEC. 공시 • Dec 17
DBV Technologies Regains Compliance with Nasdaq Listing Rule 5550(a)(2) On December 13, 2024, DBV Technologies S.A. (the Company") received a letter from the Listing Qualifications Staff (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that the Staff has determined that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2). The Staff determined that for 10 consecutive business days, from November 29, 2024 to December 12, 2024, the closing bid price of the Company's American Depositary Shares has been at $1.00 per share or greater. 공시 • Nov 12
DBV Technologies Announces Plan to Implement ADS Ratio Change to Regain Compliance DBV Technologies S.A. announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per share, from the current ADS Ratio of one (1) ADS to one (1) ordinary share to a new ADS Ratio of one (1) ADS to five (5) ordinary shares (the “ADS Ratio Change”). The Company anticipates that the ADS Ratio Change will be effective on or about November 29, 2024 (the “Effective Date”). For the Company’s ADS holders, the change in the ADS Ratio will have the same effect as a one-for-five reverse ADS split and is intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement. 공시 • Aug 02
Dbv Technologies S.A. Receives Feedback from FDA on Design Elements for Viaskin Peanut Safety Studies DBV Technologies announced the receipt of Written Responses from the FDA on key study design elements for the COMFORT (Characterization of the Optimal Management of FOod Allergy Relief and Treatment) Toddlers and COMFORT Children supplemental safety studies in 1 – 3-year-olds and 4 – 7-year-olds, respectively, with a peanut allergy. The Company also reported financial results for the second quarter and the first half of 2023. The quarterly and half-year financial statements were approved by the Board of Directors on July 28, 2023. Viaskin™ Peanut in 1 – 3-year-olds (original square patch) and Viaskin™ Peanut in 4 – 7-year-olds (modified circular patch) are separate product candidates with independent clinical and regulatory paths supporting two distinct Biologics License Applications (BLAs). DBV received Type C Meeting Written Responses from the FDA on the two supplemental safety studies, known as COMFORT. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7-years and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. The FDA agreed with a 6-month study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. Both COMFORT studies will assess adhesion using the same tools and measurements that were established in VITESSE. Neither the COMFORT Toddlers study nor the COMFORT Children study will require an oral food challenge for participation. The feedback received is consistent with FDA’s position on COMFORT Children in 4 – 7-year-olds, as previously announced in December 2022. Both COMFORT studies aim to bring the total number of subjects on active treatment to approximately 600 participants in each age group, when added to their respective Phase 3 pivotal efficacy studies (i.e., EPITOPE and VITESSE). 공시 • Jul 26
DBV Technologies S.A. to Report First Half, 2023 Results on Jul 31, 2023 DBV Technologies S.A. announced that they will report first half, 2023 results on Jul 31, 2023 
