Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • Mar 25
DBV Technologies S.A., Annual General Meeting, May 16, 2024 DBV Technologies S.A., Annual General Meeting, May 16, 2024. Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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 Anuncio • 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. Anuncio • 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. Anuncio • 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). Anuncio • 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 Seeking Alpha • Jul 07
DBV Technologies: Good Data, Plenty Of Cash And Regulatory Uncertainty DBV Technologies is a French company traded on Nasdaq which is developing treatments for food allergies.
Their technology is a patch that delivers a very small daily dose of the allergen to desensitize the patient.
The company previously received a CRL due to issues with the adhesion properties of their patch.
The Phase 3 EPITOPE trial met the primary endpoint with a good safety profile.
FDA feedback on the regulatory path is the next critical catalyst for the company.
DBV Technologies (DBVT) is developing an epicutaneous (on the skin) delivery system for the treatment of food allergies including peanuts and milk. After completing a Phase 3 trial in children ages 4-11, the company received a CRL from the FDA for their Viaskin peanut patch due to concerns about patch adhesion. The company redesigned the patch and will need to run a new Phase 3 trial using the modified patch for this age group. Recently, using the unmodified patch, the EPITOPE study met the primary endpoint in children ages 1-4. DBV Technologies is well capitalized after a recent raise that occurred after the EPITOPE readout. There is considerable uncertainty about the regulatory path but longer term these assets, if approved have significant value.
Peanut Allergies and Treatment Options
There are more than one million children in the US with peanut allergies. The prevalence in babies is increasing and as many as 5% of babies have a peanut allergy. Avoidance of peanuts is the primary strategy but accidental exposure can result in severe reactions.
Allergy treatments gradually increase the quantity of allergen that a child is exposed to. The goal of treatment is to desensitize the child and increase the quantity of peanut that elicits an allergic reaction.
There are no FDA-approved treatments for peanut allergies in children ages 1-3. At age 4, children would become eligible for Palforzia which is an oral immunotherapy. It is newly approved and can only be prescribed by a trained allergist and requires an FDA mandated risk mitigation plan due to the risk of anaphylaxis.
In the Palforzia program, under the supervision of a trained physician, children ingest increasing amounts of peanut protein. Dose escalation occurs in a certified physician’s office. At dose escalation, 67 % of patients reported abdominal pain, 36.5% experienced vomiting, 32% reported nausea and 31% reported oral itching. There was a 9.4 % rate of anaphylaxis during dose escalation and 8.7% during maintenance dosing. At the end of treatment, 67% of Palforzia patients could tolerate a 600 mg dose of peanuts. (600 mg is approximately 2 peanuts).
The EPITOPE study met the primary endpoint
Toddlers aged 1-3 who have a peanut allergy were enrolled in the clinical trial. On a daily basis, their caregivers applied a Viaskin peanut patch. The patch at the highest dose contains 250 micrograms of peanut protein which is a very, very small amount of peanut protein. (A microgram is one thousandth of an mg.)
The EPITOPE trial was one year in duration. 244 toddlers received treatment and 118 received placebo. At baseline and at the end of treatment, toddlers received a food challenge to determine their eliciting dose. The eliciting dose is the amount of peanut that causes allergic symptoms. At the end of treatment, patients who were successfully treated made the improvements shown in the chart below.
Before Treatment
After Treatment
Eliciting dose less than or equal to 10 mg
Eliciting dose greater than or equal to 300 mg
Eliciting dose greater than 10 mg
Eliciting dose greater than or equal to 1000 mg
Source: DBV Technologies
67% of children treated met the "success" response criteria at 12 months. In comparison, 33.5 % of placebo treated children met the endpoint. (Note: The placebo response was likely a result of a self resolving peanut allergy.) This result was statistically significant and the primary endpoint was met.
In the trial, there was one SAE which was swelling around the eye. The most common side effect was a reaction at the site where the patch was applied. 22.5 % of the children experienced a site reaction that was severe as compared to 8.5% of placebo patients. These reactions decreased during the one year treatment period. Eight children discontinued treatment due to side effects.
Four children (1.6%) treated with Viaskin Peanut experienced an anaphylactic reaction that was determined to be or may have been related to treatment. None of these anaphylactic reactions were serious. Three of these reactions resolved with epinephrine and one without epinephrine. A long term open label extension study is underway.
Revenue Projections