DBV Technologies (NASDAQ: DBVT) reports positive Phase 3 VITESSE peanut trial

Rhea-AI Filing Summary

DBV Technologies S.A. reported that it has issued a press release announcing positive topline results from its Phase 3 VITESSE trial of the VIASKIN Peanut Patch in peanut allergic children aged 4-7 years. This current report on Form 8-K attaches the full press release as an exhibit and incorporates it by reference.

The announcement marks a late-stage clinical milestone for the company’s peanut allergy program in young children. By formally furnishing the press release through the SEC, DBV signals that the Phase 3 VITESSE outcome for the VIASKIN Peanut Patch in 4- to 7-year-olds is an important development for its pipeline.

Positive

• DBV Technologies announced positive topline results from the Phase 3 VITESSE trial of the VIASKIN Peanut Patch in peanut allergic children aged 4-7 years.

Negative

• None.

Insights

Biotech and clinical-trials analyst

Positive Phase 3 topline results for DBV’s peanut patch represent a key late-stage milestone in its pediatric allergy program.

DBV Technologies reports positive topline results from its Phase 3 VITESSE trial evaluating the VIASKIN Peanut Patch in peanut allergic children aged 4-7 years. Phase 3 studies are typically larger, later-stage clinical trials designed to confirm a therapy’s effectiveness and safety in the intended patient group.

Focusing on peanut allergic children aged 4-7 highlights a clearly defined pediatric population, where new treatment options can be especially meaningful for families managing everyday allergy risk. The company’s decision to highlight these positive topline data in a dedicated report and press release underlines the importance of VITESSE for its overall peanut patch program.

For market participants, Phase 3 outcomes are often central to how a development-stage therapy is viewed, because they summarize how the product performed in a pivotal setting. In this case, the disclosed information emphasizes that the VITESSE trial for the VIASKIN Peanut Patch in young children produced positive topline results, with further detail available in the attached press release.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

December 16, 2025

Date of Report (Date of earliest event reported)

DBV Technologies S.A.

(Exact name of registrant as specified in its charter)

France		001-36697		Not applicable
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

107 avenue de la République 92320 Châtillon France		Not Applicable
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: +33 1 55 42 78 78

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary shares, nominal value €0.10 per share		n/a		The Nasdaq Stock Market LLC *
American Depositary Shares, each representing five ordinary shares, nominal value €0.10 per share		DBVT		The Nasdaq Stock Market LLC

* Not for trading, but only in connection with the registration of the American Depositary Shares on The Nasdaq Stock Market LLC.

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On December 16, 2025, DBV Technologies S.A. (the “Company”) issued a press entitled “DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN^® Peanut Patch in Peanut Allergic 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit		Description
99.1		Press Release dated December 16, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.

				DBV Technologies S.A.
Date: December 16, 2025				By:		/s/ Daniel Tassé
				Name:		Daniel Tassé
				Title:		Chief Executive Officer

FAQ

What did DBV Technologies (DBVT) report in this SEC filing?

DBV Technologies reported that it issued a press release announcing positive topline results from its Phase 3 VITESSE trial of the VIASKIN Peanut Patch in peanut allergic children aged 4-7 years.

What is the Phase 3 VITESSE trial mentioned by DBV Technologies (DBVT)?

The Phase 3 VITESSE trial is described as a late-stage clinical study evaluating the VIASKIN Peanut Patch in peanut allergic children aged 4-7 years, for which DBV reported positive topline results.

Which patient group is targeted by DBV Technologies VIASKIN Peanut Patch in the VITESSE study?

The VIASKIN Peanut Patch in the VITESSE Phase 3 trial is being studied in peanut allergic children aged 4-7 years, according to DBV Technologies.

How did DBV Technologies (DBVT) communicate the Phase 3 VITESSE results to investors?

DBV Technologies furnished a press release as Exhibit 99.1 to a Form 8-K, announcing the positive topline results from the Phase 3 VITESSE trial of the VIASKIN Peanut Patch.

When did DBV Technologies announce the positive VITESSE topline results?

DBV Technologies stated that it issued the press release titled “DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN Peanut Patch in Peanut Allergic Children Aged 4-7 Years” on December 16, 2025.