DBV Technologies (DBVT) FDA Approvals $11.85 -1.12 (-8.64%) Closing price 09/11/2026 04:00 PM EasternExtended Trading$11.86 +0.01 (+0.04%) As of 09/11/2026 05:55 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsInsider TradesNews and TrendsOptions ChainOwnershipSEC FilingsShort Interest DBV Technologies' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by DBV Technologies (DBVT). Over the past two years, DBV Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Viaskin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Viaskin Peanut (EPITOPE) FDA Regulatory Events Viaskin Peanut (EPITOPE) is a drug developed by DBV Technologies for the following indication: Peanut-allergic toddlers ages 1 to 3 years. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Data Presentation - February 10,2026Data Presentation Drug: Viaskin Peanut (EPITOPE)Announced Date: February 10, 2026Indication: Peanut-allergic toddlers ages 1 to 3 yearsAnnouncementDBV Technologies announced that the company will present additional data for the VIASKIN® Peanut Patch in children ages 4-7 years from the positive VITESSE Phase 3 study at the American Academy of Allergy, Asthma, and Immunology 2026 Annual Meeting, taking place in Philadelphia, PA February 27-March 2, 2026.AI SummaryDBV Technologies will present additional data from the positive VITESSE Phase 3 study of the VIASKIN® Peanut Patch in children ages 4–7 at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2026 Annual Meeting in Philadelphia, PA, Feb 27–Mar 2, 2026. The oral abstract titled “VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children 4 Through 7 Years of Age” is scheduled for Feb 28, 2026, 2:15–2:25pm ET in the Clinical Science in Food Allergy session and will be presented by David Fleischer, MD. DBV will also host a product theater on Feb 28, 10:00–10:30am ET, titled “Epicutaneous Immunotherapy (EPIT): Shaping the Future of Pediatric Food Allergy Treatment,” with panelists Hugh Sampson, MD; Katherine Anagnostou, MD, MSc, PhD; and S. Shahzad Mustafa, MD. Attendees can visit DBV at booth #1527 to learn more about EPIT and the VIASKIN Peanut Patch, early intervention, and how these approaches may change peanut allergy management.Read AnnouncementFDA Meeting Request - March 24,2025Fda Meeting Request FDA Type D MeetingDrug: Viaskin Peanut (EPITOPE)Announced Date: March 24, 2025Indication: Peanut-allergic toddlers ages 1 to 3 yearsAnnouncementDBV Technologies announced that in a Written Responses Only to the Company's Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group.AI SummaryDBV Technologies announced that the FDA has agreed—in a Written Responses Only to the Company’s Type D IND meeting request—that the safety exposure data from the VITESSE Phase 3 study will be sufficient for a Biologics License Application (BLA) for the Viaskin peanut patch in children aged 4 to 7 years. This agreement means that the supplemental COMFORT Children safety study is no longer required, allowing DBV to accelerate its BLA submission timeline to the first half of 2026. The decision is based on robust safety data generated from active treatment participants and those who crossed over to the open-label extension, covering over 500 children on Viaskin peanut patch treatment at the time of submission. The FDA’s alignment with DBV is seen as a major step forward in providing a new treatment option for children with peanut allergies.Read Announcement DBV Technologies FDA Events - Frequently Asked Questions Has DBV Technologies received FDA approval? As of now, DBV Technologies (DBVT) has not received any FDA approvals for its therapy in the last two years. What drugs has DBV Technologies submitted to the FDA? In the past two years, DBV Technologies (DBVT) has reported FDA regulatory activity for Viaskin Peanut (EPITOPE). What is the most recent FDA event for DBV Technologies? The most recent FDA-related event for DBV Technologies occurred on February 10, 2026, involving Viaskin Peanut (EPITOPE). The update was categorized as "Data Presentation," with the company reporting: "DBV Technologies announced that the company will present additional data for the VIASKIN® Peanut Patch in children ages 4-7 years from the positive VITESSE Phase 3 study at the American Academy of Allergy, Asthma, and Immunology 2026 Annual Meeting, taking place in Philadelphia, PA February 27-March 2, 2026." What conditions do DBV Technologies' current drugs treat? Currently, DBV Technologies has one therapy (Viaskin Peanut (EPITOPE)) targeting the following condition: Peanut-allergic toddlers ages 1 to 3 years. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Agenus FDA EventsBioLineRx FDA EventsCAMP4 Therapeutics FDA EventsCompass Pathways FDA EventsJaguar Animal Health FDA EventsLegend Biotech FDA EventsLyell Immunopharma FDA EventsMedicus Pharma FDA EventsOncolytics Biotech FDA EventsOptimi Health FDA EventsOncobiologics FDA EventsPrelude Therapeutics FDA EventsVerrica Pharmaceuticals FDA EventsAbbVie FDA EventsAscendis Pharma A/S FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies uniQure FDA Events Celldex Therapeutics FDA Events Immunome FDA Events NewAmsterdam Pharma FDA Events Zai Lab FDA Events SELLAS Life Sciences Group FDA Events Beam Therapeutics FDA Events Nurix Therapeutics FDA Events Viridian Therapeutics FDA Events Nektar Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:DBVT last updated on 2/10/2026 by MarketBeat.com Staff. 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Data Presentation - February 10,2026Data Presentation Drug: Viaskin Peanut (EPITOPE)Announced Date: February 10, 2026Indication: Peanut-allergic toddlers ages 1 to 3 yearsAnnouncementDBV Technologies announced that the company will present additional data for the VIASKIN® Peanut Patch in children ages 4-7 years from the positive VITESSE Phase 3 study at the American Academy of Allergy, Asthma, and Immunology 2026 Annual Meeting, taking place in Philadelphia, PA February 27-March 2, 2026.AI SummaryDBV Technologies will present additional data from the positive VITESSE Phase 3 study of the VIASKIN® Peanut Patch in children ages 4–7 at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2026 Annual Meeting in Philadelphia, PA, Feb 27–Mar 2, 2026. The oral abstract titled “VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children 4 Through 7 Years of Age” is scheduled for Feb 28, 2026, 2:15–2:25pm ET in the Clinical Science in Food Allergy session and will be presented by David Fleischer, MD. DBV will also host a product theater on Feb 28, 10:00–10:30am ET, titled “Epicutaneous Immunotherapy (EPIT): Shaping the Future of Pediatric Food Allergy Treatment,” with panelists Hugh Sampson, MD; Katherine Anagnostou, MD, MSc, PhD; and S. Shahzad Mustafa, MD. Attendees can visit DBV at booth #1527 to learn more about EPIT and the VIASKIN Peanut Patch, early intervention, and how these approaches may change peanut allergy management.Read Announcement
FDA Meeting Request - March 24,2025Fda Meeting Request FDA Type D MeetingDrug: Viaskin Peanut (EPITOPE)Announced Date: March 24, 2025Indication: Peanut-allergic toddlers ages 1 to 3 yearsAnnouncementDBV Technologies announced that in a Written Responses Only to the Company's Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group.AI SummaryDBV Technologies announced that the FDA has agreed—in a Written Responses Only to the Company’s Type D IND meeting request—that the safety exposure data from the VITESSE Phase 3 study will be sufficient for a Biologics License Application (BLA) for the Viaskin peanut patch in children aged 4 to 7 years. This agreement means that the supplemental COMFORT Children safety study is no longer required, allowing DBV to accelerate its BLA submission timeline to the first half of 2026. The decision is based on robust safety data generated from active treatment participants and those who crossed over to the open-label extension, covering over 500 children on Viaskin peanut patch treatment at the time of submission. The FDA’s alignment with DBV is seen as a major step forward in providing a new treatment option for children with peanut allergies.Read Announcement
