DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results...

$DBVT
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
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Recent Analyst Ratings for
$DBVT

DatePrice TargetRatingAnalyst
1/4/2023Hold → Buy
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12/16/2022Neutral → Sell
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9/14/2021Hold → Buy
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$DBVT
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  • DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved

    Châtillon, France, March 27, 2025 DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved DBV secures $125.5 million (€116.3 million) up front and up to $181.4 million (€168.2 million), subject to the full exercise of warrantsDBV sufficiently funded through the expected Biologics License Application (BLA) submission to Food and Drug Administration (FDA) for the Viaskin® peanut patch in children 4 – 7-years-old and commercial launch, if approvedDBV will host an investor conference call on Monday, March 31st at 5:00pm ET (23h00 CET) to discuss the fi

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  • DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results...

    Châtillon, France, March 24, 2025 DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin® Peanut Patch in 4 – 7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, and Reports 2024 Unaudited Financial Results1 COMFORT Children supplemental safety study in children 4 – 7-years-old no longer required FDA confirms safety exposure data generated from VITESSE Phase 3 clinical study and VITESSE Open-Label Extension (OLE) are sufficient to support a Biologics License Application (BLA) for Viaskin peanut patch in children 4 – 7-years-oldVITESSE topline results on-track for the fourth quarter of 2025

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  • DBV Technologies to Participate in Upcoming AAAAI/WAO Joint Congress

    Châtillon, France, February 25, 2025 DBV Technologies to Participate in Upcoming AAAAI/WAO Joint Congress DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, today announced that the company will participate in the American Academy of Allergy, Asthma, and Immunology and World Allergy Organization (AAAAI/WAO) Joint Congress, February 28-March 3, 2025, in San Diego, CA. An oral abstract presentation by Dr. David Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Children's Hospital Colorado, will describe Month 60 (M60), end-of-study efficacy and safety results from PEOPLE (the open-label extension of the 12-month, double-blind placebo-controlled, Phase 3 PEPITES

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  • DBV Technologies Reports First Quarter 2024 Financial Results and Business Update

    Montrouge, France, May 7, 2024 DBV Technologies Reports First Quarter 2024 Financial Results and Business Update VITESSE enrollment on track to screen last patient by Q3 2024Appointment of Robert Pietrusko, PharmD to Chief Regulatory OfficerQ1 2024 closes with a cash balance of $101.5 million DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the first quarter 2024. The quarterly financial statements were approved by the Board of Directors on May 7, 2024. Recent

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  • DBV Technologies Announces Appointment of Virginie Boucinha as Chief Financial Officer

    Montrouge, France, October 16, 2023 DBV Technologies Announces Appointment of Virginie Boucinha as Chief Financial Officer DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the appointment of Virginie Boucinha as its Chief Financial Officer, effective November 6, 2023. An experienced financial and operations executive, Virginie will report directly to Daniel Tassé, Chief Executive Officer, and serve as a member of the Executive Committee. "I am pleased to welcome Virginie to the DBV Executive Committee to lead our global financial organization," said Daniel Tassé, Chief Executive Officer, DBV Tech

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  • DBV Technologies Announces Appointment of New Chair of its Audit Committee and Appointment of Daniele Guyot-Caparros to Board of Directors

    Montrouge, France, October 3, 2022 DBV Technologies Announces Appointment of New Chair of its Audit Committee and Appointment of Daniele Guyot-Caparros to Board of Directors DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that Mr. Timothy E. Morris, Independent Director and Member of the Audit Committee of the Board of Directors ("the Board"), was appointed as Chairperson of the Board's Audit Committee in replacement of Ms. Viviane Monges, who resigned from the Board effective October 3, 2022. DBV also announced the Board's provisional appointment of Ms. Daniele Guyot-Caparros as Independent Director to fill Ms. Monges' vacancy, effective October

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  • DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study

    Châtillon, France, January 8th, 2025 DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE    DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company's proposed labeling approach shared with FD

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  • DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

    Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-oldCompany to host investor webcast today at 5:00pm ET DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company, tod

    $DBVT
    Biotechnology: Biological Products (No Diagnostic Substances)
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  • DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe

    Châtillon, France, October 22, 2024 DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track for 4Q 2025  European Medicines Agency (EMA) scientific advice confirms registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1 – 7

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