DBV Technologies Announces Submission of Biologics License Application to U.S. FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years

The application is supported by Phase 3 VITESSE results that DBV describes as positive, with Priority Review requested.

Rhea-AI Summary

DBV Technologies (DBVT) has submitted a U.S. FDA approval application for the VIASKIN Peanut Patch in children aged 4–7 with peanut allergy. The submission is a Biologics License Application, the request for permission to market a biological treatment. DBV has requested Priority Review; the FDA previously granted the patch Breakthrough Therapy Designation.

The application is supported by Phase 3 VITESSE results that DBV describes as positive. The trial enrolled 654 children, randomly assigned 2:1 to the patch or placebo, across 86 sites. It evaluated the efficacy and safety of the 250 µg patch using a double-blind design, with participants and investigators unaware of treatment assignments. Its primary endpoint compares the percentage of treatment responders in the active and placebo groups after 12 months.

3 points · 1 major

PositiveiHow this balance works

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0 major · 0 points

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Positive

• Major pointPhase 3 VITESSE results in 654 children were described by DBV as positive.
• Moderate pointFDA application submitted for VIASKIN Peanut Patch in children aged 4–7 with peanut allergy.
• Minor pointBreakthrough Therapy Designation was previously granted by the FDA for the VIASKIN Peanut Patch.

Negative

• None.

Key Figures

Trial enrollment: 654 children Randomization: 2:1 Trial sites: 86 sites +3 more

Trial enrollment

654 children

VITESSE Phase 3 trial, ages 4–7

Randomization

2:1

VIASKIN Peanut Patch or placebo

Trial sites

86 sites

VITESSE Phase 3 trial

Patch dose

250 µg

VITESSE study

Primary endpoint assessment

12 months

Difference in treatment-responder percentages, active versus placebo

Open-label extension

Up to 3 years

Total time on treatment

Key Terms

biologics license application, priority review, breakthrough therapy designation, epicutaneous immunotherapy

4 terms

biologics license application regulatory

"submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

priority review regulatory

"DBV has requested Priority Review of the BLA."

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

breakthrough therapy designation regulatory

"The FDA previously granted Breakthrough Therapy Designation to the VIASKIN® Peanut Patch."

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

epicutaneous immunotherapy medical

"The VIASKIN® Patch uses epicutaneous immunotherapy (EPIT)"

Epicutaneous immunotherapy is a treatment that delivers tiny, controlled doses of an allergen through a patch applied to the skin to retrain the immune system and reduce allergic reactions over time. Think of it as a slow, measured exposure training the body to tolerate a trigger rather than avoiding it entirely. Investors watch this approach because it represents a potentially safer, easier-to-administer alternative to injections or pills, with implications for market size, regulatory approval, and long-term treatment adoption in allergy therapeutics.

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Châtillon, France, September 29, 2026

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 reflects years of rigorous clinical development, meaningful contributions from the entire food allergy community, and ongoing collaboration with the FDA. We are grateful for the Agency’s constructive engagement over the last few months and look forward to working closely with them during the review process.”

The VIASKIN® Patch uses epicutaneous immunotherapy (EPIT), an innovative, non-oral, non-injection approach to food allergy treatment that delivers small amounts of an allergen protein through the skin. By using the immune properties of the skin, the VIASKIN® Peanut Patch is designed to progressively desensitize children to peanut allergy.

The BLA is supported by the positive results from the VITESSE Phase 3 clinical trial of the VIASKIN® Peanut Patch in 654 children ages 4 through 7 years with peanut allergy. VITESSE is the largest immunotherapy clinical trial to date for this population.

About the VITESSE Study
VITESSE (NCT05741476) is a global Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of the VIASKIN® Peanut patch (250 µg) in children ages 4-7 years with peanut allergy. The study enrolled 654 children randomized 2:1 to receive either VIASKIN® Peanut Patch or placebo. Conducted at 86 sites across the United States, Canada, United Kingdom, Europe, and Australia, VITESSE represents the largest immunotherapy clinical trial for this patient population. The primary endpoint is the difference between the percentage of treatment responders in the active versus placebo group after 12 months of treatment. Following the 12-month double-blind period, children were given the option to continue into an open-label extension where all participants receive VIASKIN® Peanut Patch for up to a total of three years on treatment.

About DBV Technologies
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 is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309).

For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.

Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of VIASKIN® Peanut patch and EPIT, results of DBV’s clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans, timing and expectations with respect to priority review of the BLA for VIASKIN® Peanut Patch for children ages 4 through 7, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates 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, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, DBV Technologies’ Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026 filed with the SEC on April 30, 2026 and July 16, 2026, respectively, and future filings and reports made with the AMF and SEC by DBV. 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.

VIASKIN is a registered trademark of DBV Technologies.

Investor Relations Contact
Virginie Boucinha
DBV Technologies
Virginie.boucinha@dbv-technologies.com

Media Contact
Brett Whelan
DBV Technologies
Brett.whelan@dbv-technologies.com 

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FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What FDA approval has DBV Technologies requested for VIASKIN Peanut Patch?

DBV submitted a Biologics License Application for VIASKIN Peanut Patch in children with peanut allergy aged 4 through 7 years. The company also requested Priority Review of the application.

Can children continue treatment after DBV's VITESSE trial?

After the 12-month double-blind period, children were given the option to enter an open-label extension, where all participants receive VIASKIN Peanut Patch. The extension allows up to a total of three years on treatment.