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Current Report · Items 8.01, 9.01 · 8-K
DBVTFOTCEQUITYCurrent
Item 8.01. Other Events On September 29, 2026, DBV Technologies S.A. (the “Company”) issued a press release entitled “DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
DBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® Patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through 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. DBV Technologies is committed to transforming the care of people with food allergies. 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.
DBV Technologies S.A. · 8-K · Filed 2026-09-30
Exhibit 99.1 DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN ® Peanut Patch in Children Aged 4-7 Years The BLA is supported by the results from the successful Phase 3 VITESSE trial – the largest immunotherapy clinical trial to date for this population. DBV has requested Priority Review of the BLA. DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today announced that the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the VIASKIN® Peanut Patch in children with peanut allergy aged 4 through 7 years. DBV has requested Priority Review of the BLA. The FDA previously granted Breakthrough Therapy Designation to the VIASKIN® Peanut Patch. “The submission of our BLA brings VIASKIN® Peanut Patch, a non-invasive, practical treatment option, one step closer to being available for children ages 4 through 7 living with peanut allergy, and marks a significant milestone in DBV’s transformation into a commercial organization,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “This BLA re…
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