Duyuru • 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 Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • 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 Duyuru • 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. Duyuru • 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. Duyuru • 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 Duyuru • 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. Duyuru • 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. Duyuru • 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. Duyuru • Oct 23
Dbv Technologies Announces Positive Regulatory Updates for the Viaskin Peanut Patch in the United States and Europe DBV Technologies announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV has agreed to guidance provided by the U.S. Food and Drug Administration on a pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old and has also received scientific advice from the EMA on a 1 – 7 year-old indication in Europe. DBV intends to formalize the Accelerated Approval guidance provided by the FDA via submission of a meeting request. Viaskin Peanut Patch in Toddlers 1 – 3 Years. Accelerated Approval Pathway, FDA guidance for Accelerated Approval include three qualifying criteria: 1) that the product treats a serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. FDA confirmed that DBV has met criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which DBV has agreed to in informal discussions with the FDA. DBV intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. DBV expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved. COMFORT Toddlers DBV is pleased to have aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 - 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 year-olds under the Accelerated Approval program is anticipated to be supported by: i. Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and ii. Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in Second Quarter 2025. DBV and FDA are in general agreement that the confirmatory study will need to demonstrate the effectiveness of the Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. DBV will prioritize initiation of the COMFORT Toddlers safety study to enable the BLA submission. DBV and the FDA have been engaged in ongoing dialogue regarding the COMFORT Toddlers supplemental safety study in 1 – 3 year-olds with a peanut allergy. The focus of continued exchanges has been on patch adhesion, specifically: The hierarchy of an adhesion assessment within the COMFORT Toddlers study (FDA requesting that it be a study objective vs. exploratory assessment); The sufficiency of adhesion data collected during the EPITOPE study to fully characterize daily patch adhesion duration (wear time) given the EPITOPE adhesion data collection methodology, and, conversely, the collection methodology required to generate sufficient adhesion data to inform the Viaskin label in future studies; and the clinical relevance and regulatory use of adhesion data collected in a study that does not include an efficacy assessment. Viaskin Peanut Patch in Children 4 – 7, In September 2024, DBV announced that patient screening had been completed for the Phase 3 efficacy trial of the Viaskin Peanut patch in peanut allergic children ages 4 – 7 years-old (VITESSE). A total of 654 subjects were enrolled, and DBV anticipates topline data in the fourth quarter of 2025. The COMFORT Children safety study is expected to be initiated in the second quarter of 2025. This study plans to enroll approximately 250 subjects to raise the total number of 4 – 7 year-olds on active treatment across the development program to approximately 600, consistent with prior FDA guidance. These two studies will constitute the core studies for a BLA submission in 4 – 7 year-olds. Duyuru • Jul 29
DBV Technologies S.A. to Report Q2, 2024 Results on Jul 30, 2024 DBV Technologies S.A. announced that they will report Q2, 2024 results on Jul 30, 2024 Duyuru • Jun 20
DBV Technologies Provides Non-Compliance Update Related to Nasdaq Listing Rule 5550(a)(2) & 5810(c)(3)(A) On December 22, 2023, DBV Technologies S.A. (the Company) reported that it had received a letter from the Listing Qualifications Department of the Nasdaq Stock Market on December 20, 2023 regarding the Company’s failure to comply with Nasdaq Continued Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. A failure to comply with Rule 5550(a)(2) exists when listed securities fail to maintain a closing bid price of at least $1.00 per share for 30 consecutive business days. Under Rule 5810(c)(3)(A), the Company automatically was provided a period of 180 calendar days, until June 17, 2024, to regain compliance. On June 18, 2024, the Company was notified by the Listing Qualifications Department that Nasdaq granted the Company’s request to transfer the listing of its American Depositary Shares (“ADSs”) from The Nasdaq Global Select Market tier to The Nasdaq Capital Market tier, and that Nasdaq granted the Company’s request for a second 180-calendar day period, or until December 16, 2024 (the “Second Compliance Period”), to regain compliance with the $1.00 bid price requirement, as set in Rule 5550(a)(2). To regain compliance with such minimum price requirement, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days. The transfer of the listing of the ADSs from The Nasdaq Global Select Market tier to The Nasdaq Capital Market tier will take effect with the open of business on June 20, 2024. The transfer is not expected to impact trading in the ADSs, which will continue to trade on Nasdaq under the symbol “DBVT.” In the event that the Company is not able to cure the bid price deficiency during the Second Compliance Period, Nasdaq will provide written notice that the ADSs will be delisted; however, the Company may request a hearing before the Nasdaq Hearings Panel (the “Panel”), which request, if timely made, would stay any further suspension or delisting action by Nasdaq pending the conclusion of the hearing process and expiration of any extension that may be granted by the Panel. Although the Company will use all reasonable efforts to achieve compliance with Rule 5550(a)(2), there can be no assurance that the Company will be able to regain compliance with that rule or will otherwise be in compliance with other Nasdaq listing criteria. Duyuru • Mar 25
DBV Technologies S.A., Annual General Meeting, May 16, 2024 DBV Technologies S.A., Annual General Meeting, May 16, 2024. Duyuru • Mar 05
DBV Technologies S.A. to Report Fiscal Year 2023 Results on Mar 07, 2024 DBV Technologies S.A. announced that they will report fiscal year 2023 results on Mar 07, 2024 Duyuru • Dec 22
DBV Technologies Receives a Letter from the Listing Qualifications Staff of the Nasdaq Stock Market On December 20, 2023, DBV Technologies S.A. received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC notifying the Company that for the last 30 consecutive business days, the bid price of the Company's American Depositary Shares had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). The notification received has no immediate effect on the listing of the Company's ADSs on the Nasdaq Stock Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days, or until June 17, 2024, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company's ADSs must be at least $1.00 per share for a minimum of ten consecutive business days before the Compliance Date. If the Company's ADSs do not achieve compliance by the Compliance Date, the Company may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. The Company intends to actively monitor the closing bid price of its ADSs between now and the Compliance Date and will evaluate available options to resolve the deficiency and regain compliance with the minimum bid price rule. Duyuru • Nov 03
DBV Technologies S.A. to Present New Data at ACAAI 2023 DBV Technologies S.A. announced that new data on the use of Viaskin™ Peanut (DBV712) 250 µg in peanut-allergic toddlers will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, which is being held November 9 – November 13, 2023, in Anaheim, CA. A late-breaking oral abstract has been accepted by the ACAAI and will be presented on the interim 12-month results from the ongoing Phase 3 open-label extension to the EPITOPE trial (EPOPEX) trial of Viaskin™ Peanut in peanut-allergic toddlers. The meeting will also feature a “Product Theater” on Individualizing Peanut Allergy Management: A Case-based Panel Discussion. Drs. Douglas Mack, David Stukus, and Julie Wang will engage in a discussion around the factors influencing peanut allergy management, such as use of food challenges and effects of comorbidities, using various patient scenarios. Viaskin Peanut is the Company’s lead product candidate designed to reduce the risk of allergic reactions due to accidental exposure to peanuts. An investigational, non-invasive, once-daily epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to re-educate the immune system. The safety and efficacy of Viaskin Peanut have not yet been established by the U.S. Food and Drug Administration or the European Medicines Agency. Duyuru • Oct 28
DBV Technologies S.A. to Report Q3, 2023 Results on Oct 31, 2023 DBV Technologies S.A. announced that they will report Q3, 2023 results on Oct 31, 2023 Duyuru • Oct 18
DBV Technologies S.A. Announces Executive Changes On October 16, 2023, DBV Technologies S.A. announced the appointment of Virginie Boucinha as the Company’s Chief Financial Officer and principal accounting officer, effective as of November 6, 2023. In addition, the Company announced that Sébastien Robitaille, who currently serves as the Company’s Chief Financial Officer, will separate employment with the Company effective November 17, 2023 to pursue other opportunities. Ms. Boucinha, 53, has served as Group Performance Director of the Pierre Fabre Group, a pharmaceutical company, since February 2022. Prior to Pierre Fabre Group, Ms. Boucinha spent over fifteen years through July 2021 with Sanofi, a pharmaceutical manufacturing company, where she served in progressively senior finance and operational leadership roles. In her most recent roles, she was the Global Transformation Office Head from May 2018 to July 2021, where she was a member of the senior leadership team responsible for company structural organization and governance redesign and implementation, and Chief of Staff to the CEO from July 2015 to March 2018, where she handled the chief executive officer and executive committee agenda and coordination, the chief executive officer briefing and strategic projects. Ms. Boucinha is a graduate of Ecole Superieure de Gestion where she obtained a Master of Business Administration. Duyuru • Oct 17
DBV Technologies S.A. Appoints Virginie Boucinha as Principal Accounting Officer, Effective as of November 6, 2023 On October 16, 2023, DBV Technologies S.A. announced the appointment of Virginie Boucinha as the Company’s Chief Financial Officer and principal accounting officer, effective as of November 6, 2023. In addition, the Company announced that Sébastien Robitaille, who currently serves as the Company’s Chief Financial Officer, will separate employment with the Company effective November 17, 2023 to pursue other opportunities. Ms. Boucinha, 53, has served as Group Performance Director of the Pierre Fabre Group, a pharmaceutical company, since February 2022. Prior to Pierre Fabre Group, Ms. Boucinha spent over fifteen years through July 2021 with Sanofi, a pharmaceutical manufacturing company, where she served in progressively senior finance and operational leadership roles. In her most recent roles, she was the Global Transformation Office Head from May 2018 to July 2021, where she was a member of the senior leadership team responsible for company structural organization and governance redesign and implementation, and Chief of Staff to the CEO from July 2015 to March 2018, where she handled the chief executive officer and executive committee agenda and coordination, the chief executive officer briefing and strategic projects. Ms. Boucinha is a graduate of Ecole Superieure de Gestion where she obtained a Master of Business Administration. Duyuru • 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). Duyuru • 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 Duyuru • Dec 23
DBV Technologies Announces FDA Lifts Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial DBV Technologies announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical trial that will evaluate the modified Viaskin™ Peanut 250 µg patch (DBV712) in peanut-allergic children ages 4 to 7 years. The updated protocol will be submitted to study sites for subsequent Institutional Review Boards (IRB)/Ethics Committees (EC) approval. In the Partial Clinical Hold (PCH) letter, the FDA requested changes to certain elements of the VITESSE protocol with the intent for the trial to support a Biologics License Application (BLA). The FDA communication contained four protocol modifications: the redefinition of the minimal daily wear time, the addition of a statistical test for the patch adhesion assessment, the reclassification of certain adverse events (AEs) to adverse events of special interest (AESIs) and an increase in the number of trial participants on active treatment. Key design elements of VITESSE such as inclusion criteria, primary efficacy endpoint, responder criteria, efficacy assessment methodology and safety endpoints were not impacted by the PCH letter and have not changed. Following receipt of the PCH letter, DBV and the FDA discussed how VITESSE protocol modifications could best support the Agency’s review of a potential BLA for Viaskin Peanut as a peanut allergy treatment. In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter. The FDA stated that DBV may proceed with VITESSE with the following changes included in the revised protocol: The updated VITESSE Instructions for Use (IFU) will direct caregivers to apply one patch at approximately the same time each day, following removal of the previous day’s patch. The updated IFU now outlines that Viaskin Peanut 250 µg is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day. Patch adhesion will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies. In post-PCH discussions, DBV and the FDA agreed a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform. Four AEs will be classified as AESIs. These AEs – which include AEs leading to inhaled or systemic corticosteroid or epinephrine use, systemic allergic reactions, and Grade 4 local application site (skin) reactions – were collected and assessed in all previous Viaskin Peanut trials and included in the previous VITESSE protocol. Only the classification of these AEs has changed. DBV plans to initiate a separate safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo. The additional safety data generated by this six-month study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. The protocol design of the safety study will be submitted to the FDA and is expected to be similar to the REALISE (REAL Life Use and Safety of EPIT) safety study that DBV previously conducted with Viaskin Peanut in children ages 4 to 11 years. The Company does not expect the additional safety study to have an impact on the Company’s cash runway guidance as DBV had included a provision for a possible supplemental safety trial in its cash runway assumptions. The Company reiterates that cash on-hand is sufficient to fund operations through VITESSE topline data. DBV anticipates initiating VITESSE patient screening in the first quarter of 2023 with the last patient screened in the first half of 2024 and topline results anticipated in the first half of 2025. Duyuru • Oct 05
DBV Technologies S.A. Announces Executive Changes DBV Technologies S.A. announced that Mr. Timothy E. Morris, Independent Director and Member of the Audit Committee of the Board of Directors, was appointed as Chairperson of the Boards Audit Committee in replacement of Ms. Viviane Monges, who resigned from the Board effective October 3, 2022. DBV also announced the Boards provisional appointment of Ms. Daniele Guyot-Caparros as Independent Director to fill Ms. Monges vacancy, effective October 3, 2022. With these changes, the Board comprises 10 members. Mr. Morris has been a member of DBV Technologies Board and Audit Committee since April 2021. Mr. Morris has served as the Chief Operating Officer and Chief Financial Officer of Humanigen Inc. since August 2020. He currently serves on the board of Aquestive Therapeutics, Univercells S.A. and Humanetics (private). Mr. Morris has 38 years of professional finance and accounting experience, including 25 years as Chief Financial Officer of public biotechnology companies. Ms. Monges served as a Member of the Companys Board and Audit Committee since May 2019 and Chairperson of the Boards Audit Committee since March 2021. The Board of DBV Technologies has finalized the provisional appointment of a new Independent Director to fill the vacancy left by Ms. Monges and to join the Audit Committee of the Board. Ms. Daniele Guyot-Caparros joins as a new Independent Director to the Board, subject to ratification by the Companys shareholders at the next annual meeting of shareholders, and as a Member of the Boards Audit Committee. Ms. Guyot-Caparros has a longstanding track record in finance and business operations. She began her career in audit and corporate finance with PricewaterhouseCoopers (PwC) and later joined Rhne-Poulenc-Rorer (later Aventis and Sanofi) where she held several senior finance positions including Chief Financial Officer, Global Research and Development and Chief Financial Officer, Europe, Group Planning. Ms. Guyot-Caparros also held responsibilities in business development, pricing and portfolio management. In 2008, Ms. Guyot-Caparros became Senior Advisor for Deloitte France to support the development of the Life Sciences and Health Care Industry practice. In addition to in-house experience, Ms. Guyot-Caparros has held positions on the boards of biotechnology and medical technology companies. She was both a Board Member and Audit Committee Member at Diaxonhit (now Eurobio Scientific), listed on Euronext Growth. Ms. Guyot-Caparros was also Chairperson of the Audit Committee of Supersonic Imagine from July 2018 to September 2019 until its acquisition. From 2013 to 2022, she has been the Chairperson of the Audit Committee of Onxeo, and also served as the Chairperson of its Board of Directors from May 2019 to July 2021. Duyuru • Sep 23
DBV Technologies S.A. Receives Feedback from the U.S. Food and Drug Administration in the Form of a Partial Clinical Hold on Its VITESSE Phase 3 Clinical Study DBV Technologies S.A. announced that it received feedback from the U.S. Food and Drug Administration (FDA) in the form of a partial clinical hold on its VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical study. In the partial clinical hold letter, the FDA specifies changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission. Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment. DBV has not yet begun the screening or recruitment of subjects in the VITESSE study. The partial clinical hold is specific to VITESSE and does not impact any other ongoing DBV clinical studies. The Company expects to provide additional updates following consultation with the FDA. VITESSE is a Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin™ Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years. Duyuru • Sep 08
DBV Technologies S.A. Announces Initiation of Phase 3 Study (VITESSE) Using the Modified Viaskin Peanut Patch in Peanut -Allergic Children Ages 4 to 7 Years DBV Technologies S.A. announced the initiation of the Phase 3 study, VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), using the modified Viaskin™ Peanut Patch, in peanut-allergic children ages 4 to 7 years. The study was initiated following productive exchanges with the U.S. Food and Drug Administration (FDA). The protocol has been submitted to study sites for subsequent Institutional Review Boards (IRB)/Ethics Committees (EC) approval. DBV expects to enroll 600 subjects for participation in the VITESSE study, randomized 2:1 active to placebo. The first patient screened is expected in Fourth Quarter 2022 with the last patient screened by year-end 2023. The Company anticipates that the topline results will read out in First Quarter 2025. Dr. David Fleischer, Colorado Children’s Hospital, will act as the Principal Investigator for the VITESSE study, which will involve approximately 80 study sites across the U.S., Canada, Australia, Europe and the U.K. Over the last several months, DBV and the FDA have engaged in ongoing discussions on the epicutaneous immunotherapy (EPIT™) platform as a novel drug -device combination for delivering allergen immunotherapy and on the VITESSE trial design. These interactions determined that VITESSE will evaluate the efficacy and safety of the modified Viaskin Peanut patch as a peanut allergen immunotherapy, which may potentially support a future BLA submission. Following productive discussions, the FDA granted DBV a Type C meeting in May 2022 to align on the VITESSE study. The study protocol was submitted to the FDA as part of the Type C briefing materials. Subsequent exchanges between DBV and the FDA ensued to align on critical design elements and endpoints, and these were included in the final protocol that was sent to study sites. VITESSE is a Phase 3, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years. The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at month 12. The primary efficacy analysis includes the success criterion of the lower bound of the confidence interval of the difference in responder rates between active and placebo groups being greater than or equal to 15%. DBV defined the VITESSE inclusion criteria to address the high unmet need of younger, more sensitive peanut allergy patients. In food allergy market research and quality of life studies, caregivers report being highly motivated to protect their child from a reaction to an accidental allergen ingestion and prevent food allergy from negatively impacting their child’s quality of life. Caregivers cite stressors specific to younger age groups, such as a child’s inability to self-manage their food allergy, transitions to more independent environments such as daycare and school, and a perception that food allergy will increasingly impact their child’s quality of life. The decision to target the 4 to 7-year-old age group reflects careful review of post-hoc analyses of PEPITES (Peanut EPITEfficacy and Safety) efficacy data in peanut-allergic children ages 4 to 11 years, and consideration of the recently announced EPITOPE (EPIT in TOddlers with PEanut Allergy) data in toddlers ages 1 to 3 years. The VITESSE age inclusion criterion aligns the protocol with an age cohort of peanut allergy patients who have demonstrated a higher response rate in previous peanut allergy treatment studies. Duyuru • Jun 14
DBV Technologies S.A. announced that it has received €82.00136 million in funding from Vivo Capital, LLC, RA Capital Management, L.P., VR Adviser, LLC, Baker Bros. Advisors LP, Braidwell LP, Fairmount Funds Management LLC On June 13, 2022, DBV Technologies S.A. closed the transaction. Duyuru • Jun 11
DBV Technologies S.A. announced that it expects to receive €82.00136 million in funding from Vivo Capital, LLC, RA Capital Management, L.P., VR Adviser, LLC, Baker Bros. Advisors LP, Braidwell LP, and other investor DBV Technologies S.A. announced that it will issue pre-funded warrants to purchase up to 28,276,331 ordinary shares at a price of €2.90 per pre-funded warrant, for gross proceeds of €82,001,359.9 in a round of funding on June 9, 2022. The pre-funded warrants will be sold to the purchasers at a pre-funded price of €2.90 per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. The transaction included participation from Braidwell LP for €17.6947 million ($19 million), Baker Bros. Advisors LP for €38.1833 million ($41 million), Venrock Healthcare Capital Partners Fund, L.P., a fund managed by VR Adviser, LLC for €26.0764 million ($28 million), other investors in the private placement include Fairmount, RA Capital Management, L.P., and Vivo Capital, LLC. The closing of the PIPE financing is subject to customary closing conditions and is expected to close on June 13, 2022. Duyuru • Jun 08
DBV Technologies Announces Positive Topline Results from Phase 3 Epitope Trial of Viaskin Peanut in Peanut-Allergic Toddlers DBV Technologies announced that its pivotal Phase 3 trial EPITOPE (EPIT in TOddlers with PEanut Allergy), assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4%; 95% CI = 22.4% - 44.5%). DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population. Separately, DBV continues productive dialogue with the U.S. Food and Drug Administration (FDA) on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut-allergic children ages 4 years and older. These results represent the second and final part of the EPITOPE trial, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. The median subject baseline eliciting dose (ED) was 100 mg in each treatment arm. A double-blind, placebo-controlled food challenge (DBPCFC) was administered at baseline and month 12 to determine a subject’s ED at each timepoint. A treatment responder was defined as either a subject with a baseline ED =10 mg who reached an ED =300 mg of peanut protein at month 12, or a subject with a baseline ED >10 mg who reached an ED =1,000 mg of peanut protein at month 12. In an additional pre-specified efficacy analysis, treatment response was defined as achieving an ED =1,000 mg of peanut protein regardless of baseline ED. Using this response criterion, Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 64.2% of subjects in the Viaskin Peanut arm meeting this treatment responder criterion after 12 months as compared to 29.6% of subjects in the placebo arm (difference in response rates = 34.7%; 95% CI = 23.6% - 45.7%). The response rate observed in the placebo arm appears consistent with the approximately 22% natural resolution rate in this patient population. The EPITOPE safety results were generally consistent with the safety profile of Viaskin Peanut 250 µg observed in children with peanut allergy ages 4 years and older in prior clinical trials. No imbalance in the overall adverse event (AE) rate was observed in the trial between the active and placebo arms. Overall, 21 subjects (8.6%) in the Viaskin Peanut arm and 3 subjects (2.5%) in the placebo arm experienced a serious adverse event (SAE). Only 1 of the SAEs (0.4%), which was mild periorbital edema (swelling around the eye) in the Viaskin Peanut arm, was deemed related to treatment. The most commonly reported adverse events were skin reactions localized to the administration site, the majority of which were mild to moderate in nature. Fifty-five subjects (22.5%) in the Viaskin Peanut arm experienced an application site reaction that was assessed as severe by an investigator compared with 10 subjects (8.5%) in the placebo arm. Based on investigators’ reported observations from examinations of the skin at each study visit, using the skin grading systems defined in the protocol, the severity of administration site skin reactions following patch application decreased throughout the course of the 12-month treatment period. Four (1.6%) subjects in the Viaskin Peanut arm experienced an anaphylactic reaction determined to be related to, or possibly related to, treatment. Among these anaphylactic reactions, 3 resolved with a single dose of epinephrine and 1 resolved without epinephrine. All anaphylactic reactions were mild to moderate in severity and were characterized mainly by skin and respiratory symptoms. Eight subjects (3.3%) in the Viaskin Peanut arm discontinued due to adverse events. Duyuru • Dec 21
DBV Technologies S.A. Provides Update on Investigational Viaskin Peanut 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. Duyuru • Feb 22
DBV Technologies Announces Appointment of Michele F. Robertson as Chief Legal Officer DBV Technologies announced the appointment of Michele F. Robertson as its Chief Legal Officer, effective immediately. An experienced attorney, Michele will act as the lead corporate counsel for DBV, reporting directly to Daniel Tassé, Chief Executive Officer, and serving as a member of the Executive Committee. Michele will be responsible for legal, compliance, and intellectual property activities. She will provide the senior executive team with legal and regulatory guidance to support the pursuit of DBV’s key objectives. Michele brings more than 15 years of experience in legal and strategic business development in the life sciences and pharmaceutical industries. She most recently served as a member of the Executive Leadership Team at Mallinckrodt Pharmaceuticals, where she served as the General Counsel, Commercial Operations and Chief Compliance Officer. Duyuru • Jan 16
DBV Technologies Provides Update on Investigational Viaskin™ Peanut for Children Ages 4-11 Years DBV Technologies announced the receipt of written responses from the U.S Food and Drug Administration (FDA) to questions provided in the Type A meeting request the Company submitted in October 2020. The Type A meeting request was submitted following the Company’s receipt of a Complete Response Letter (CRL) in connection with its Biologics License Application (BLA) for Viaskin™ Peanut (DBV712), an investigational, non-invasive, once-daily epicutaneous patch to treat peanut allergy in children ages 4 to 11 years. DBV believes that the feedback received from the FDA provides a well-defined regulatory path forward. In exchanges with the FDA, DBV proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. DBV will address details about a new human factor (HF) validation study and additional chemistry, manufacturing and controls (CMC) data in subsequent interactions with the FDA. The FDA agreed with DBV's position that a modified Viaskin™ Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin™ Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin™ Peanut patch in the intended patient population. DBV plans to initiate the selection of modified prototype patches in the first quarter of 2021. Additionally, DBV will submit the protocol for the safety and adhesion trial in children with peanut allergy to FDA for review and comments in the second quarter of 2021 before initiating the trial. Based on the guidance received from the FDA and DBV’s plans to implement such guidance, DBV continues to expect that the organization-wide cost reduction measures resulting from its previously announced global restructuring plan will extend its cash runway to the second half of 2022. Duyuru • Nov 24
Hugh Sampson Decides to Step Down as Chief Scientific Officer of DBV Technologies, Effective December 1, 2020 DBV Technologies announced that Dr. Hugh Sampson has decided to step down from his role as Chief Scientific Officer (CSO) at DBV, effective December 1, 2020, to return to his research program at the Jaffe Food Allergy Institute at Mount Sinai. While acting as CSO, Dr. Sampson continued his commitment to the food allergy community by directing his research lab, running a NIH-sponsored prevention trial, and seeing patients in clinical practice part-time. Dr. Sampson will take on a new role as Scientific Adviser to the Chief Executive Officer and Chairman of DBV’s Scientific Advisory Board. In this capacity, he will remain involved in DBV’s ongoing development of epicutaneous immunotherapy (EPIT™). After three years serving on DBV’s Scientific Advisory Board, Dr. Sampson joined DBV in 2015 to formally lead the Company’s global scientific efforts and explore potential new applications of investigational Viaskin™ for the treatment of food allergies and autoimmune disorders, and for the development of novel vaccines. Duyuru • Nov 10
DBV Technologies to Highlight Data on Viaskin™ Peanut Treatment Delivery and Patient Experience at ACAAI 2020 DBV Technologies S.A. announced that new analyses of clinical studies investigating epicutaneous immunotherapy to treat peanut allergy with a patch (DBV712 250 µg) will be presented at the virtual American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, Nov. 13-15, 2020. Four abstracts have been accepted, including one oral presentation and three poster presentations. DBV will also host a virtual booth in the ACAAI virtual exhibit hall. The data to be presented include assessment of clinical study patient experiences, the impact of patch adhesion and duration of patch application on treatment response, and the performance of an assay for predicting desensitization to peanut. These analyses contribute to the continued characterization of the benefit:risk profile of DBV712 250 µg. DBV is sponsoring an industry symposium during the conference about the impact of COVID-19 on managing food allergies. Dr. Matthew Greenhawt, Associate Professor, Pediatrics and Director, Food Challenge and Research Unit, Children’s Hospital Colorado, University of Colorado, will discuss the recent expert panel consensus aiming to guide decision-making in allergy and immunology clinics during the pandemic with a focus on best practices for food allergy care, as well as implications for the future of the field. DBV is also sponsoring the 29th Annual FIT Bowl, a game show that tests the knowledge of participating teams from training programs around the country. Duyuru • Nov 02
DBV Technologies S.A. Announces Filing and Validation of Marketing Authorization Application for Viaskin™ Peanut by European Medicines Agency DBV Technologies S.A. announced that its Marketing Authorization Application for its investigational product Viaskin™ Peanut (DBV712) has been validated by the European Medicines Agency. The validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process for the investigational non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years. Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the application and provide a recommendation to the European Commission (EC) on whether to grant a marketing authorization. DBV expects to receive the first set of questions from the EMA approximately 120 days post-validation. In August 2020, the Company announced that it had received a Complete Response Letter (CRL) from the U.S Food and Drug Administration (FDA) for its Biologics License Application (BLA) for investigational Viaskin™ Peanut. The Company is in the process of engaging FDA to discuss the regulatory path forward. 
