DBVT DBV Technologies S.A.

4.2
-0.1  -2%
Previous Close 4.3
Open 4.29
52 Week Low 2.02
52 Week High 13.49
Market Cap $460,915,442
Shares 109,741,772
Float 109,741,772
Enterprise Value $299,731,605
Volume 103,674
Av. Daily Volume 210,809
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Upcoming Catalysts

Drug Stage Catalyst Date
Viaskin Peanut
Peanut allergy - ages 4 to 11 years
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Drug Pipeline

Drug Stage Notes
Viaskin Peanut (EPITOPE)
Peanut allergy - ages 1 to 3 years
Phase 3
Phase 3
Phase 3 (Part B) enrolment expectations due 2H 2020.
Viaskin Milk
Cow’s milk protein allergy (CMPA)
Phase 1/2
Phase 1/2
Phase 1/2 data released February 2018.

Latest News

  1. Montrouge, France, July 7, 2020

    DBV Technologies Announces Publication of PEOPLE Phase III Open-Label Extension Study Evaluating Viaskin Peanut in The Journal of Allergy and Clinical Immunology

    PEOPLE is the largest long-term peanut allergy immunotherapy trial to date and showed favorable benefit-to-risk across three-year treatment period with Viaskin Peanut

    DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that The Journal of Allergy and Clinical Immunology (JACI) has published results from its three-year, open-label extension of the Phase III PEPITES study (PEOPLE). The study was published online today and will be in an upcoming print edition of the journal.

    Patients demonstrated durable, long-term…

    Montrouge, France, July 7, 2020

    DBV Technologies Announces Publication of PEOPLE Phase III Open-Label Extension Study Evaluating Viaskin Peanut in The Journal of Allergy and Clinical Immunology

    PEOPLE is the largest long-term peanut allergy immunotherapy trial to date and showed favorable benefit-to-risk across three-year treatment period with Viaskin Peanut

    DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that The Journal of Allergy and Clinical Immunology (JACI) has published results from its three-year, open-label extension of the Phase III PEPITES study (PEOPLE). The study was published online today and will be in an upcoming print edition of the journal.

    Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment with Viaskin™ Peanut (compound name DBV712 250 μg), with low discontinuations due to adverse events. Top-line data from PEOPLE were announced in January 2020 and presented with additional detail at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Annual Meeting in March. The Biologics License Application (BLA) for investigational DBV712 for peanut-allergic children ages 4-11 years is currently under review by the U.S. Food and Drug Administration (FDA). If approved, DBV712 would be the first once-daily, non-invasive epicutaneous treatment option for children living with peanut allergy.

    "These data from the largest long-term study of peanut allergy immunotherapy demonstrate continued treatment benefit of DBV712 beyond one year, as well as a decrease in adverse events," said David Fleischer, M.D., Principal Investigator of PEPITES and PEOPLE, Professor of Pediatrics and Section Head, Children's Hospital Colorado. "In my clinical practice, I see many patients and their families who struggle with the burden of peanut allergy and the fear of accidental exposure. The potential benefit of an easy to use, well-tolerated treatment with long-term effect would be a welcome option for these patients."

    PEOPLE Efficacy Results

    Data from the PEOPLE trial demonstrate that DBV712 was associated with continued response over a three-year treatment period.

    • 75.9% (107/141) saw an improvement in eliciting dose (ED) from baseline to Month 36.
    • 51.8% (73/141) achieved an ED of at least 1,000 mg at Month 36.
    • At Month 36, the mean cumulative reactive dose (CRD) was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.
    • A treatment effect was seen across the spectrum of baseline sensitivity, including the most sensitive patients; those who entered with an ED of less than or equal to 10 mg (n=18) saw a 22.5-fold increase in geometric mean ED over the treatment period.
    • Consistent with the high rate of sustained unresponsiveness reported in a previous clinical study1, exploratory analyses in a subset of participants showed that 77.8% (14/18) were able to maintain desensitization, according to predefined study definition, for a two-month period while off therapy and without peanut consumption.

    PEOPLE Safety and Tolerability Results

    A favorable tolerability profile was observed with DBV712 in the PEOPLE trial, consistent with that observed in the clinical program to date in nearly 1,000 participants.

    • The most commonly reported treatment-emergent adverse events (TEAEs) were application site reactions, which decreased in frequency and severity over time. No treatment-related serious adverse events (SAEs) were reported.
    • One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment; it resolved without treatment and the patient continued participation in the study. 
    • There was no epinephrine use deemed related to treatment.
    • Treatment compliance remained high throughout PEPITES and PEOPLE at a mean of 98%. Most withdrawals were due to fear or aversion to a double-blind, placebo-controlled food challenge.

    "We are pleased that JACI has published the PEOPLE trial results, ensuring that healthcare providers will have access to these important data supporting an epicutaneous immunotherapy approach to treating one of the most common food allergies in children," said Pharis Mohideen, M.D., Chief Medical Officer of DBV Technologies, "We believe that data from this landmark study in peanut-allergic children ages 4-11 support the potential long-term treatment benefit in this patient population."

    About PEOPLE

    The PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut (DBV712 250 μg) (NCT03013517). Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE. Patients who were randomized to active treatment in PEPITES are eligible to receive up to four additional years of treatment, and those previously receiving placebo are eligible to receive up to five years of treatment.

    The study evaluates the eliciting dose after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC). The starting dose of each challenge is 1 mg of peanut protein and escalates to the highest dose of 2,000 mg peanut protein (possibly repeated once to reach a maximum total cumulative dose of 5,444 mg peanut protein). For the planned DBPCFCs after four and five years of treatment, the starting dose of each challenge is 10 mg of peanut protein and escalates to the highest dose of 3,000 mg peanut protein (possibly repeated once to reach a maximum total cumulative dose of 6,440 mg peanut protein).

    The analysis also includes exploratory assessments of safety parameters, immune biomarkers such as immunoglobulin E (IgE) and immunoglobulin G4 (IgG4), and sustained unresponsiveness following a two-month period without treatment.

    About DBV Technologies 

    DBV Technologies is developing Viaskin®, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV's method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV's food allergies programs include ongoing clinical trials of Viaskin Peanut (DBV712). DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Company's ordinary shares are traded on segment B of Euronext Paris (NYSE:DBV, ISIN code: FR0010417345))), part of the SBF120 index, and the Company's ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (NASDAQ:DBVT).

    Forward Looking Statements

    This press release may contain forward-looking statements and estimates, including statements regarding the potential of Viaskin™ Peanut (DBV712) as a treatment for peanut-allergic children, the conduct and timing of the Company's clinical trial of Viaskin Peanut and the Company's research, development and regulatory plans for DBV712 and its other product candidates, including the Company's planned interactions with the FDA regarding DBV712 and the target action date for the Company's BLA. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the products of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals. Furthermore, the timing of any action by the FDA and possible regulatory paths forward cannot be guaranteed. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorité des Marchés Financiers, the Company's Securities and Exchange Commission filings and reports, including in the Company's Annual Report on Form 20-F for the year ended December 31, 2019, and future filings and reports by the Company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

    DBV Contact

    Sara Blum Sherman

    Senior Director, Investor Relations & Strategy

    +1 212-271-0740

    __________________________

    [1] Brown-Whitehorn TF, De Blay F, Sampson H. Allergy (EAACI) 2018. Sustained unresponsiveness following long term Epicutaneous Immunotherapy (EPIT) with VIASKIN® peanut: Results of the OLFUS‐ VIPES PHASE IIb Study. Allergy [Internet]. 2018 Aug 14. Available from: https://onlinelibrary.wiley.com/doi/10.1111/all.13537

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  2. Montrouge, France, June 26, 2020

    DBV Technologies Provides Operational and Business Update

    BLA review of Viaskin Peanut for the treatment of peanut allergy in children ages 4-11 years ongoing

    Company to immediately initiate restructuring plan to extend cash runway while awaiting FDA clarity

    EPITOPE Phase III trial in toddlers ages 1-3 years ongoing; treatment benefit observed in Part A analysis   

    DBV Technologies (the "Company") (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that given the Company has not yet received an update from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Viaskin™ Peanut, it has undergone a comprehensive business review to best…

    Montrouge, France, June 26, 2020

    DBV Technologies Provides Operational and Business Update

    BLA review of Viaskin Peanut for the treatment of peanut allergy in children ages 4-11 years ongoing

    Company to immediately initiate restructuring plan to extend cash runway while awaiting FDA clarity

    EPITOPE Phase III trial in toddlers ages 1-3 years ongoing; treatment benefit observed in Part A analysis   

    DBV Technologies (the "Company") (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that given the Company has not yet received an update from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Viaskin™ Peanut, it has undergone a comprehensive business review to best position DBV for the possibility of a delay in timelines for the Viaskin Peanut BLA review. As a result, the Board of Directors has approved the immediate initiation of a global and comprehensive restructuring plan, which is expected to include a significant reduction in workforce. The Company has initiated, in compliance with French law, the mandatory consultation process with DBV's Social and Economic Committee in France.

    "We have carefully reviewed the situation and given the prevailing uncertainties, the goal of the plan that we are launching aims to preserve our core functions, extend our cash runway and maintain operating latitude to bring the first and only epicutaneous immunotherapy for the treatment of peanut allergy to patients in need, if approved," said Daniel Tassé, Chief Executive Officer of DBV Technologies. "We continue to believe Viaskin Peanut, based on the clinical data observed to date, can change the long-term treatment paradigm of peanut allergies and lend itself well to this current healthcare environment."

    Financial and Business Updates:

    As communicated on March 16, 2020, FDA notified DBV that it had questions regarding the impact of patch adhesion on efficacy. The Company promptly submitted additional data analyses that DBV believes addressed the questions put forward by the FDA and asked the FDA to provide feedback on the path forward. These data analyses, which showed that the majority of patients treated with Viaskin Peanut achieved sufficient daily application duration to experience clinical benefit, have also been published in two peer-reviewed publications1,2. Following submission of the data analyses in April and requests for discussion, FDA did not provide further information beyond that the data was being reviewed and the target action date of August 5, 2020 remains unchanged. Given the absence of clarity from the FDA, DBV is implementing a restructuring plan that will provide the flexibility to continue the BLA review process, prepare to bring Viaskin Peanut to patients, if approved, and preserve the Company's cash runway.

    DBV plans to focus on Viaskin Peanut and scale down other clinical programs and pre-clinical spend. The Company is contemplating the implementation of cost reduction measures across the organization, while preserving core activities and competencies. Under the revised plan and proposed cost structure, DBV now expects that its current balance of cash and cash equivalents of €262.4 million at the end of the first quarter of 2020 will be sufficient to fund operations significantly beyond the prior guidance of the first quarter of 2021. Following feedback from FDA on the Viaskin Peanut BLA review, the Company will provide updated financial guidance.

    Clinical Trials Update:

    All ongoing clinical trials will continue as planned; however, enrollment timelines have been impacted by COVID-19. The Company's global collaboration with Nestlé Health Science to develop diagnostic product candidates will also continue as planned, subject to the impact of COVID-19. During this unprecedented time, DBV will continue to take additional measures as required to preserve the safety of its employees and mitigate potential impact of COVID-19 on the Company's business.

    The Company also provided an update on the ongoing EPITOPE trial, a two-part, pivotal Phase III clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic toddlers ages 1 to 3 years, to complement the proposed indication in children ages 4 to 11 years currently under FDA review. As previously reported, Part A showed that both doses studied (100 µg (n=20) and 250 µg (n=21)) were reported to be well tolerated, with no treatment-related serious adverse events (SAEs). Patients in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 µg dose in this age group, which is the dose being studied in Part B of the study.

    Based on the current COVID-19 pandemic and uncertainty surrounding study enrollment, the Company anticipates providing an update regarding sample size and expectations for completion of enrollment of Part B in the second half of 2020. The Company will evaluate potential options including adjusting the target enrollment for Part B.

    "These initial data from EPITOPE, our second Phase III clinical trial for Viaskin Peanut, provide support for an epicutaneous immunotherapy approach to treating food allergy in this age group," said Pharis Mohideen, M.D., Chief Medical Officer of DBV Technologies. "There is a growing body of scientific evidence that supports the importance of treating peanut-allergic patients from a young age, when they are most likely to be diagnosed. These findings are important not only for understanding the science of epicutaneous immunotherapy in different age groups, but also for advancing a potential treatment option for very young patients."

    About EPITOPE

    EPITOPE is expected to enroll approximately 400 patients (51 in Part A and 350 in Part B) in approximately 50 centers across North America (Canada and the United States), Europe, and Australia. The EPITOPE trial is a two-part trial: Part A was designed to assess the safety of Viaskin Peanut 100 µg and 250 µg and to determine the highest safe dose, and Part B is designed to assess the efficacy and safety of the selected dose. In Part A, 51 patients were randomized 1:2:2 to receive either placebo or Viaskin Peanut 100 μg or 250 μg. A planned safety analysis by the independent Data Safety and Monitoring Board (DSMB) was performed after three months of treatment to determine the highest safe dose to be studied in Part B. There were no safety concerns observed with either of the two doses, and patients will continue on their respective treatment and remain on the same active dose or placebo they received in Part A up to month-12. In Part B, patients will be randomized 2:1 to receive Viaskin Peanut 250 µg or placebo.

    The primary endpoint is based on a responder analysis after 12 months of treatment with the selected dose of Viaskin Peanut. Efficacy will be assessed using a double-blind, placebo-controlled food challenge (DBPCFC). For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. As a secondary efficacy endpoint, Cumulative Reactive Dose (CRD), will also be evaluated in EPITOPE to establish the total quantity of peanut protein that triggers patient reactions at month 12 of active treatment versus placebo. Serological markers will also be measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.

    Following the completion of EPITOPE, all eligible patients will have the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin Peanut 250 µg. Patients enrolling in the EPOPEX study will remain blinded to their respective treatment group in EPITOPE until the EPITOPE study results become publicly available.

    About DBV Technologies

    DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV's method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV's food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical trial of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Company's ordinary shares are traded on segment B of Euronext Paris (NYSE:DBV, ISIN code: FR0010417345))), part of the SBF120 index, and the Company's ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (NASDAQ:DBVT).

    Forward Looking Statements

    This press release may contain forward-looking statements and estimates, including statements regarding the potential benefits of the proposed restructuring of the Company's business and potential cost savings, the timelines for the Company's ongoing clinical trials, including in light of the ongoing impact of the COVID-19 pandemic, the potential of Viaskin™ Peanut as a treatment for peanut-allergic children, the conduct and timing of the Company's clinical trials of Viaskin Peanut and the Company's research, development and regulatory plans for its product candidates and preclinical pipeline, including the Company's planned interactions with the FDA regarding Viaskin Peanut and the target action date for the Company's BLA. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the products of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, including the impact of the COVID-19 pandemic, and the Company's ability to successfully execute on its restructuring plans. Furthermore, the timing of any action by the FDA and possible regulatory paths forward cannot be guaranteed. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorité des Marchés Financiers, the Company's Securities and Exchange Commission filings and reports, including in the Company's Annual Report on Form 20-F for the year ended December 31, 2019, and future filings and reports by the Company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

    DBV Investor Relations Contact

    Sara Blum Sherman

    Senior Director, Investor Relations & Strategy

    +1 212-271-0740

    DBV Media Contact

    Joe Becker

    VP, Global Corporate Communications

    +1 646-650-3912

    __________________________

    [1] Fleischer DM, Chinthrajah S, et al. An Evaluation of Factors Influencing Response to Epicutaneous Immunotherapy For Peanut Allergy in the PEPITES Trial. Allergy & Asthma Proceedings. 2020;41:1-10. doi:10.2500/aap.2020.41.200047.

    [2] Fleischer DM, Spergel JM, et al. Evaluation of Daily Patch Application Duration For Epicutaneous Immunotherapy For Peanut Allergy. Allergy & Asthma Proceedings. 2020;41:278-284. doi:10.2500/aap.2020.41.200045.

     

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  3. Monthly information regarding the total number of voting rights and
    total number of shares of the Company as of May 31, 2020

    (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers)

    Market : NYSE Euronext Paris
    ISIN Code: FR 0010417345

     

    Date

     
    Total number of shares Total number of voting rights
    05/31/202054,927,187 

    Total gross of voting rights: 54,927,187

     
     

    Total net* of voting rights:  54,870,886

     

    * Total net = total number of voting rights attached to shares – shares without voting rights

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    Monthly information regarding the total number of voting rights and

    total number of shares of the Company as of May 31, 2020

    (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers)

    Market : NYSE Euronext Paris

    ISIN Code: FR 0010417345

     



    Date



     
    Total number of shares Total number of voting rights
    05/31/202054,927,187 



    Total gross of voting rights: 54,927,187



     
     



    Total net* of voting rights:  54,870,886



     

    * Total net = total number of voting rights attached to shares – shares without voting rights

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  4. Montrouge, France, June 4, 2020

    DBV Technologies to Present Data on Epicutaneous Immunotherapy and Food Allergy Quality of Life at EAACI Digital Congress 2020

    Virtual presentations will include data about children with and without multiple food allergies from the pivotal Phase III peanut allergy immunotherapy trial PEPITES

    Biologics License Application for investigational Viaskin Peanut under review with U.S. Food and Drug Administration

    DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that seven abstracts, including four late breakers, highlighting new data from the Company's pre-clinical and clinical food allergy programs were accepted at the European Academy of Allergy & Clinical Immunology (EAACI…

    Montrouge, France, June 4, 2020

    DBV Technologies to Present Data on Epicutaneous Immunotherapy and Food Allergy Quality of Life at EAACI Digital Congress 2020

    Virtual presentations will include data about children with and without multiple food allergies from the pivotal Phase III peanut allergy immunotherapy trial PEPITES

    Biologics License Application for investigational Viaskin Peanut under review with U.S. Food and Drug Administration

    DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that seven abstracts, including four late breakers, highlighting new data from the Company's pre-clinical and clinical food allergy programs were accepted at the European Academy of Allergy & Clinical Immunology (EAACI) Digital Congress, June 6-8, 2020. The virtual oral and poster presentations will be available on the EAACI website to conference registrants starting Saturday, June 6 at 9:00am CEST / 3:00am EDT through December of this year. 

    "The data we are presenting at this year's digital EAACI congress highlight potential applications of epicutaneous immunotherapy across patient populations as well as new insights into promising cellular pathways for biomarker identification," said Pharis Mohideen, M.D., Chief Medical Officer of DBV Technologies. "These presentations highlight the breadth of research DBV is conducting on the science and impact of food allergy as part of our commitment to improving the lives of patients through innovative potential treatments like epicutaneous immunotherapy. Our lead candidate, Viaskin Peanut, is currently under FDA review, and we look forward to making this investigational therapy available for patients as soon as possible, if approved."

    Viaskin™ Peanut is an investigational therapy which aims to deliver biologically active compounds to the immune system through the skin to potentially safeguard peanut-allergic children in the event of accidental exposure to peanut. The Viaskin Peanut Biologics License Application, which received Breakthrough (2015) and Fast Track (2012) designations by U.S. Food and Drug Administration (FDA), is currently under review with a target action date of August 5.

    Abstracts of Interest:

    Oral Presentations:

    "Efficacy and Safety of Epicutaneous Immunotherapy (EPIT) for Peanut Allergy in Subjects With and Without Concomitant Food Allergies" will be presented by Philippe Bégin, M.D., PhD, Université de Montréal, Allergy and clinical immunology section, CHU Sainte-Justine

    • Abstract Number: 1362
    • Session Title: Novel Perspectives on Diagnosis and Management of Food Allergy

    Late Breaker: "Differences in Epitome Response in Peanut-Allergic Subjects Treated with Different Immunotherapy Preparations" will be presented by Dianne Campbell, M.D., University of Sydney, Department of Allergy and Immunology, and Vice President of Clinical Development & Medical Affairs at DBV Technologies (joint submission with AllerGenis, Stanford University and Imperial College London)

    • Abstract Number: 1776
    • Session Title: Immunotherapy: From Bench to Bedside

    Late Breaker: "Epicutaneous Immunotherapy in Murine Model Modulates Humoral Immunity Through Regulation of IL-13+ T Follicular Helper Cells" will be presented by Vincent Dioszeghy, PhD, DBV Technologies

    • Abstract Number: 1739
    • Session Title: Immunotherapy: From Bench to Bedside

    Late Breaker: "Distinct Contribution of Skin Dendritic Cell Subsets to the Efficacy of Epicutaneous Immunotherapy in Murine Models of Food Allergy" will be presented by Leo Laoubi, PhD Fellow, DBV Technologies (Oral Presentation)

    • Abstract Number: 1747
    • Session Title: Immunotherapy: From Bench to Bedside

    Poster Presentations:

    "Evaluation of Psychometric Parameters of Food Allergy Quality-of-Life Questionnaires With Item Response Theory for the Assessment of Health-Related Quality of Life during Food Allergy Treatments" will be presented by Audrey Dunn Galvin, M.D., University College Cork, Department of Pediatrics & Child Health

    • Abstract Number: 1247
    • Session Title: Food Allergy

    Late Breaker: "Quality of Life of Children and Adolescents with Food Allergy: Mapping FAQLQ-PF onto Paediatric-Specific Health State Utility Scores" will be presented by Gang Chen, PhD, Monash University

    • Abstract Number: 1719
    • Session Title: Food Allergy

    "Safety Benefits of an Increased Threshold in Milk-Allergic Patients: A Quantitative Risk Assessment Study" will be presented by Benjamin C. Remington, PhD, University of Nebraska-Lincoln Food Allergy Research and Resource Program, and the Remington Consulting Group B.V. (Affiliation during study was TNO, Netherlands)

    • Abstract Number: 1192
    • Session Title: Food Allergy

    About DBV Technologies 
    DBV Technologies is developing Viaskin®, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV's method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV's food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical trial of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Company's ordinary shares are traded on segment B of Euronext Paris (ARCA:DBV, ISIN code: FR0010417345)), part of the SBF120 index, and the Company's ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (NASDAQ:DBVT).

    Forward Looking Statements
    This press release may contain forward-looking statements and estimates, including statements regarding the potential of Viaskin Peanut and Company's regulatory plans regarding Viaskin Peanut, particularly with respect to the Company's expectations regarding its plan to resubmit its BLA to the FDA and whether any additional clinical trials may be required to support the BLA resubmission. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the products of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties related to the Company's ability to address the concerns raised by the FDA with respect to its BLA, as well as those associated with regulatory reviews and approvals and clinical trials more generally. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorité des Marchés Financiers, the Company's Securities and Exchange Commission filings and reports, including in the Company's Annual Report on Form 20-F for the year ended December 31, 2017 and future filings and reports by the Company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

    DBV Investor Relations Contact
    Sara Blum Sherman
    Senior Director, Investor Relations & Strategy
    +1 212-271-0740
    ies.com

    DBV Media Contact
    Joe Becker
    VP, Global Corporate Communications
    +1 646-650-3912

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  5. Montrouge, France, June 2, 2020

    DBV Technologies To Present at the Goldman Sachs 41st Annual Global Healthcare Conference

    DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that Daniel Tassé, Chief Executive Officer, will present at the Goldman Sachs 41st Annual Global Healthcare Conference, on Tuesday, June 9, 2020, at 1:20pm EST.

    A live webcast of the virtual presentation will be available on the Investors & Media section of the Company's website: https://www.dbv-technologies.com/investor-relations/. A replay will be available on the DBV website for 30 days following the event.

    About DBV Technologies 
    DBV Technologies is developing Viaskin®, an investigational proprietary technology platform with broad…

    Montrouge, France, June 2, 2020

    DBV Technologies To Present at the Goldman Sachs 41st Annual Global Healthcare Conference

    DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that Daniel Tassé, Chief Executive Officer, will present at the Goldman Sachs 41st Annual Global Healthcare Conference, on Tuesday, June 9, 2020, at 1:20pm EST.

    A live webcast of the virtual presentation will be available on the Investors & Media section of the Company's website: https://www.dbv-technologies.com/investor-relations/. A replay will be available on the DBV website for 30 days following the event.

    About DBV Technologies 
    DBV Technologies is developing Viaskin®, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV's method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV's food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical trial of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Company's ordinary shares are traded on segment B of Euronext Paris (ARCA:DBV, ISIN code: FR0010417345)), part of the SBF120 index, and the Company's ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (NASDAQ:DBVT).

    DBV Investor Relations Contact
    Sara Blum Sherman
    Senior Director, Investor Relations & Strategy
    +1 212-271-0740

    DBV Media Contact
    Joe Becker
    VP, Global Corporate Communications
    +1 646-650-3912

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