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DBV Technologies SA

DBV Technologies SA

DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved (Form 8-K)

DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin ® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved ● DBV secures $125.5 million (€116.3 million) up front and up to $181.4 million (€168.2 million), subject to the full exercise of warrants ● DBV sufficiently funded th ...

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31.03.2025
DBV Technologies SA

DBV Technologies SA

DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved

The text version of this document is not available. You can access the original document here . Attachments Original document Permalink Disclaimer DBV Technologies SA published this content on March 27, 2025 , and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 28, 2025 at 02:46:11.084 .

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28.03.2025
DBV Technologies SA

DBV Technologies SA

DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin® Peanut Patch in 4 - 7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, and Reports 2024 Unaudited Financial Results1 (Form 8-K)

DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin ® Peanut Patch in 4 - 7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, and Reports 2024 Unaudited Financial Results 1 • COMFORT Children supplemental safety study in children 4 - 7-years-old no longer required • FDA ...

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24.03.2025
DBV Technologies SA

DBV Technologies SA

DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7 year olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results…

DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4-7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results... Attachments Original document Permalink Disclaimer DBV Technologies SA published this content on March 24, 2025 , and is solely respo ...

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24.03.2025
DBV Technologies SA

DBV Technologies SA

DBV Technologies Announces Positive 3 Year Results from EPITOPE Phase 3 Open Label Extension Study Form 8 K

DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study • EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN ® Peanut patch in toddlers 1 - 3 years through 36 months • 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% a ...

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08.01.2025
DBV Technologies SA

DBV Technologies SA

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 3 Years Old Form 8 K

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin ® Peanut Patch in Toddlers 1 - 3 Years-Old ● DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 - 3 year-olds, including study size and wear time collection methodology and analysis ● COMFORT Toddlers study on-track to initiate in 2Q 2025 ● Viaskin Pean ...

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11.12.2024