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[8-K] DBV Technologies S.A. Reports Material Event

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

DBV Technologies announced a significant milestone in its clinical research program with the first subject screening in the COMFORT Toddlers Supplemental Safety Study, focusing on peanut-allergic children aged 1-3 years old. This development marks an important step in the company's research into peanut allergy treatments.

The company, which trades on Nasdaq under symbol DBVT through American Depositary Shares (each representing five ordinary shares), filed this 8-K to report the initiation of this clinical study. The announcement was made via press release on June 25, 2025.

Key filing details:

  • The study specifically targets toddlers between 1-3 years old with peanut allergies
  • The filing includes two exhibits: the press release (99.1) and Cover Page Interactive Data File
  • The document was signed by CFO Virginie Boucinha

DBV Technologies ha annunciato un traguardo importante nel suo programma di ricerca clinica con il primo screening di un soggetto nello studio supplementare di sicurezza COMFORT Toddlers, che coinvolge bambini allergici alle arachidi di età compresa tra 1 e 3 anni. Questo sviluppo rappresenta un passo significativo nella ricerca dell'azienda sui trattamenti per l'allergia alle arachidi.

L'azienda, quotata al Nasdaq con il simbolo DBVT tramite American Depositary Shares (ognuna rappresenta cinque azioni ordinarie), ha presentato questo modulo 8-K per comunicare l'avvio di questo studio clinico. L'annuncio è stato diffuso tramite comunicato stampa il 25 giugno 2025.

Dettagli principali della comunicazione:

  • Lo studio è specificamente rivolto a bambini piccoli tra 1 e 3 anni con allergia alle arachidi
  • La documentazione include due allegati: il comunicato stampa (99.1) e il file dati interattivo della copertina
  • Il documento è stato firmato dalla CFO Virginie Boucinha

DBV Technologies anunció un hito importante en su programa de investigación clínica con el primer cribado de un sujeto en el Estudio Suplementario de Seguridad COMFORT Toddlers, centrado en niños alérgicos al maní de entre 1 y 3 años. Este avance representa un paso crucial en la investigación de la compañía sobre tratamientos para la alergia al maní.

La empresa, que cotiza en Nasdaq bajo el símbolo DBVT mediante American Depositary Shares (cada una representa cinco acciones ordinarias), presentó este formulario 8-K para informar el inicio de este estudio clínico. El anuncio se realizó mediante un comunicado de prensa el 25 de junio de 2025.

Detalles clave del informe:

  • El estudio está dirigido específicamente a niños pequeños de 1 a 3 años con alergia al maní
  • El informe incluye dos anexos: el comunicado de prensa (99.1) y el archivo de datos interactivo de la portada
  • El documento fue firmado por la CFO Virginie Boucinha

DBV Technologies는 1~3세 땅콩 알레르기 아동을 대상으로 하는 COMFORT Toddlers 보조 안전성 연구의 첫 번째 대상자 선별이라는 임상 연구 프로그램에서 중요한 이정표를 발표했습니다. 이 발전은 회사의 땅콩 알레르기 치료 연구에 중요한 진전을 의미합니다.

미국 나스닥에서 DBVT 심볼로 거래되는 이 회사는 미국 예탁증서(각각 보통주 5주를 대표) 형태로 이번 임상 연구 시작을 알리기 위해 8-K 서류를 제출했습니다. 이 발표는 2025년 6월 25일 보도자료를 통해 이루어졌습니다.

주요 제출 내용:

  • 연구는 1~3세 땅콩 알레르기 유아를 대상으로 함
  • 서류에는 보도자료(99.1)와 표지 페이지 인터랙티브 데이터 파일 두 가지 부속 문서 포함
  • 문서는 CFO Virginie Boucinha가 서명함

DBV Technologies a annoncé une étape importante dans son programme de recherche clinique avec le premier dépistage d’un sujet dans l’étude complémentaire de sécurité COMFORT Toddlers, ciblant les enfants allergiques à l’arachide âgés de 1 à 3 ans. Ce développement marque une avancée majeure dans la recherche de l’entreprise sur les traitements contre l’allergie à l’arachide.

L’entreprise, cotée au Nasdaq sous le symbole DBVT via des American Depositary Shares (chacune représentant cinq actions ordinaires), a déposé ce formulaire 8-K pour annoncer le lancement de cette étude clinique. L’annonce a été faite par communiqué de presse le 25 juin 2025.

Détails clés du dépôt :

  • L’étude cible spécifiquement les tout-petits de 1 à 3 ans allergiques à l’arachide
  • Le dépôt comprend deux annexes : le communiqué de presse (99.1) et le fichier de données interactif de la page de couverture
  • Le document a été signé par la directrice financière Virginie Boucinha

DBV Technologies gab einen bedeutenden Meilenstein in seinem klinischen Forschungsprogramm bekannt: das erste Screening eines Probanden in der COMFORT Toddlers Ergänzenden Sicherheitsstudie, die sich auf kleinkindliche Erdnussallergiker im Alter von 1 bis 3 Jahren konzentriert. Diese Entwicklung stellt einen wichtigen Schritt in der Forschung des Unternehmens zu Erdnussallergie-Behandlungen dar.

Das Unternehmen, das an der Nasdaq unter dem Symbol DBVT über American Depositary Shares (jeweils fünf Stammaktien) gehandelt wird, reichte dieses 8-K ein, um den Beginn dieser klinischen Studie zu melden. Die Bekanntgabe erfolgte per Pressemitteilung am 25. Juni 2025.

Wichtige Details der Einreichung:

  • Die Studie richtet sich speziell an Kleinkinder im Alter von 1 bis 3 Jahren mit Erdnussallergie
  • Die Einreichung enthält zwei Anhänge: die Pressemitteilung (99.1) und die interaktive Datendatei der Titelseite
  • Das Dokument wurde von CFO Virginie Boucinha unterzeichnet

Positive
  • DBV Technologies initiated COMFORT Toddlers Supplemental Safety Study, expanding clinical trials to peanut-allergic children aged 1-3 years old, potentially broadening their addressable market
Negative
  • None.

DBV Technologies ha annunciato un traguardo importante nel suo programma di ricerca clinica con il primo screening di un soggetto nello studio supplementare di sicurezza COMFORT Toddlers, che coinvolge bambini allergici alle arachidi di età compresa tra 1 e 3 anni. Questo sviluppo rappresenta un passo significativo nella ricerca dell'azienda sui trattamenti per l'allergia alle arachidi.

L'azienda, quotata al Nasdaq con il simbolo DBVT tramite American Depositary Shares (ognuna rappresenta cinque azioni ordinarie), ha presentato questo modulo 8-K per comunicare l'avvio di questo studio clinico. L'annuncio è stato diffuso tramite comunicato stampa il 25 giugno 2025.

Dettagli principali della comunicazione:

  • Lo studio è specificamente rivolto a bambini piccoli tra 1 e 3 anni con allergia alle arachidi
  • La documentazione include due allegati: il comunicato stampa (99.1) e il file dati interattivo della copertina
  • Il documento è stato firmato dalla CFO Virginie Boucinha

DBV Technologies anunció un hito importante en su programa de investigación clínica con el primer cribado de un sujeto en el Estudio Suplementario de Seguridad COMFORT Toddlers, centrado en niños alérgicos al maní de entre 1 y 3 años. Este avance representa un paso crucial en la investigación de la compañía sobre tratamientos para la alergia al maní.

La empresa, que cotiza en Nasdaq bajo el símbolo DBVT mediante American Depositary Shares (cada una representa cinco acciones ordinarias), presentó este formulario 8-K para informar el inicio de este estudio clínico. El anuncio se realizó mediante un comunicado de prensa el 25 de junio de 2025.

Detalles clave del informe:

  • El estudio está dirigido específicamente a niños pequeños de 1 a 3 años con alergia al maní
  • El informe incluye dos anexos: el comunicado de prensa (99.1) y el archivo de datos interactivo de la portada
  • El documento fue firmado por la CFO Virginie Boucinha

DBV Technologies는 1~3세 땅콩 알레르기 아동을 대상으로 하는 COMFORT Toddlers 보조 안전성 연구의 첫 번째 대상자 선별이라는 임상 연구 프로그램에서 중요한 이정표를 발표했습니다. 이 발전은 회사의 땅콩 알레르기 치료 연구에 중요한 진전을 의미합니다.

미국 나스닥에서 DBVT 심볼로 거래되는 이 회사는 미국 예탁증서(각각 보통주 5주를 대표) 형태로 이번 임상 연구 시작을 알리기 위해 8-K 서류를 제출했습니다. 이 발표는 2025년 6월 25일 보도자료를 통해 이루어졌습니다.

주요 제출 내용:

  • 연구는 1~3세 땅콩 알레르기 유아를 대상으로 함
  • 서류에는 보도자료(99.1)와 표지 페이지 인터랙티브 데이터 파일 두 가지 부속 문서 포함
  • 문서는 CFO Virginie Boucinha가 서명함

DBV Technologies a annoncé une étape importante dans son programme de recherche clinique avec le premier dépistage d’un sujet dans l’étude complémentaire de sécurité COMFORT Toddlers, ciblant les enfants allergiques à l’arachide âgés de 1 à 3 ans. Ce développement marque une avancée majeure dans la recherche de l’entreprise sur les traitements contre l’allergie à l’arachide.

L’entreprise, cotée au Nasdaq sous le symbole DBVT via des American Depositary Shares (chacune représentant cinq actions ordinaires), a déposé ce formulaire 8-K pour annoncer le lancement de cette étude clinique. L’annonce a été faite par communiqué de presse le 25 juin 2025.

Détails clés du dépôt :

  • L’étude cible spécifiquement les tout-petits de 1 à 3 ans allergiques à l’arachide
  • Le dépôt comprend deux annexes : le communiqué de presse (99.1) et le fichier de données interactif de la page de couverture
  • Le document a été signé par la directrice financière Virginie Boucinha

DBV Technologies gab einen bedeutenden Meilenstein in seinem klinischen Forschungsprogramm bekannt: das erste Screening eines Probanden in der COMFORT Toddlers Ergänzenden Sicherheitsstudie, die sich auf kleinkindliche Erdnussallergiker im Alter von 1 bis 3 Jahren konzentriert. Diese Entwicklung stellt einen wichtigen Schritt in der Forschung des Unternehmens zu Erdnussallergie-Behandlungen dar.

Das Unternehmen, das an der Nasdaq unter dem Symbol DBVT über American Depositary Shares (jeweils fünf Stammaktien) gehandelt wird, reichte dieses 8-K ein, um den Beginn dieser klinischen Studie zu melden. Die Bekanntgabe erfolgte per Pressemitteilung am 25. Juni 2025.

Wichtige Details der Einreichung:

  • Die Studie richtet sich speziell an Kleinkinder im Alter von 1 bis 3 Jahren mit Erdnussallergie
  • Die Einreichung enthält zwei Anhänge: die Pressemitteilung (99.1) und die interaktive Datendatei der Titelseite
  • Das Dokument wurde von CFO Virginie Boucinha unterzeichnet

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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

June 25, 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 listing 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 June 25, 2025, DBV Technologies S.A. issued a press release entitled “DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 - 3 Years Old.” The full text 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
No.

  

Description

99.1    Press Release Issued June 25, 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.

 

Date: June 25, 2025     DBV TECHNOLOGIES S.A.
    By:  

/s/ Virginie Boucinha

    Name:   Virginie Boucinha
    Title:   Chief Financial Officer

FAQ

What was the purpose of DBVT's 8-K filing on June 25, 2025?

DBVT filed an 8-K to announce the initiation of their COMFORT Toddlers Supplemental Safety Study, specifically reporting that the first subject has been screened in their clinical trial for peanut allergic toddlers aged 1-3 years old.

Who signed DBVT's June 2025 8-K filing?

The 8-K filing was signed by Virginie Boucinha, who serves as the Chief Financial Officer of DBV Technologies S.A.

What exhibits were included in DBVT's June 2025 8-K filing?

The 8-K filing included two exhibits: Exhibit 99.1 (Press Release Issued June 25, 2025) and Exhibit 104 (Cover Page Interactive Data File embedded within the Inline XBRL document).

What securities does DBVT have registered on the Nasdaq Stock Market?

DBVT has two securities registered: American Depositary Shares (ADS) trading under symbol DBVT (each ADS representing five ordinary shares with €0.10 nominal value), and ordinary shares (not for trading, only in connection with the ADS listing).

Is DBVT considered an emerging growth company as of June 2025?

Based on the unchecked box in the filing, DBVT is not classified as an emerging growth company under Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
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