Dbv Technologies SA 8-K filings

DBV Technologies reported its second quarter and half-year 2026 financial results, highlighting continued engagement with the FDA for the VIASKIN Peanut Patch BLA submission anticipated in Q3 2026 and sufficient cash reserves into Q3 2027.

DBV Technologies announced a delay in its Biologics License Application submission for the VIASKIN Peanut Patch in children aged 4-7 years, now expected in Q3 2026, following FDA feedback on data formatting.

DBV Technologies has implemented a new performance-based incentive plan for CEO Daniel Tassé, granting 4.06 million share units contingent on FDA approval of Viaskin Peanut by mid-2028.

DBV Technologies S.A. announced the approval of its 2026 Performance Share Unit Plan and a significant PSU grant to CEO Daniel Tass, tied to FDA BLA acceptance for Viaskin Peanut.

DBV Technologies reports a $47.6 million net loss for Q1 2026 while maintaining a cash runway into Q2 2027.

DBV Technologies announced its full-year 2025 financial results, highlighting progress in its VIASKIN Peanut Patch clinical programs and a strengthened financial position.

DBV Technologies announced additional positive data from its Phase 3 VITESSE study for the VIASKIN Peanut Patch, showing significant desensitization in peanut-allergic children.

DBV Technologies announced the full exercise of warrants, generating €166.7 million in gross proceeds to fund operations and the potential U.S. launch of its VIASKIN Peanut patch.

DBV Technologies announced positive topline results from its pivotal Phase 3 VITESSE trial for the VIASKIN Peanut patch in peanut-allergic children aged 4-7 years, meeting its primary endpoint.

DBV Technologies S.A. announced the appointment of Dr. Philina Lee, a seasoned biopharmaceutical commercial leader, to its Board of Directors, replacing Daniel Soland.

DBV Technologies reported increased net losses and operating expenses for Q3 2025, despite a significant cash infusion, raising substantial doubt about its ability to continue as a going concern.

Daniel Soland has resigned from DBV Technologies' Board of Directors and Compensation Committee, effective immediately.

DBV Technologies has established a new At-The-Market equity offering program to raise up to $150 million through the sale of American Depositary Shares.

DBV Technologies reported a wider net loss of $69.0 million for the first half of 2025, driven by increased operating expenses, despite a significant increase in cash and cash equivalents due to recent financing that extends its runway into Q2 2026.

DBV Technologies announced the screening of the first subject in its COMFORT Toddlers supplemental safety study for the Viaskin Peanut patch in peanut-allergic children aged 1-3 years, marking a significant step in its clinical development program.

DBV Technologies S.A. announced that its shareholders approved all 39 resolutions at the Annual General Meeting on June 11, 2025, including the 2024 financial statements, executive compensation, and significant delegations for future capital raises and corporate actions.

DBV Technologies announced its Q1 2025 financial results, highlighting a decrease in cash and cash equivalents but securing financing to extend its cash runway into June 2026.

DBV Technologies announces a financing of up to $306.9 million to support the development and potential commercial launch of its Viaskin Peanut patch.

DBV Technologies announces an agreement with the FDA regarding safety exposure data for its Viaskin Peanut patch, potentially accelerating the BLA submission timeline to the first half of 2026, and reports unaudited 2024 financial results.

DBV Technologies reports positive three-year results from its EPITOPE open-label extension study, demonstrating continued improvement in treatment benefit of the Viaskin Peanut patch in toddlers.

DBV Technologies has amended employment agreements for its Chief Medical Officer and Chief Financial Officer, providing enhanced severance benefits upon a change in control.

DBV Technologies has been notified by Nasdaq that it has regained compliance with listing rules after its share price closed above $1.00 for ten consecutive days.

DBV Technologies has secured FDA alignment on an accelerated approval pathway for its Viaskin Peanut patch in toddlers aged 1-3 years, paving the way for a potential BLA submission in 2026.

DBV Technologies plans a 1-for-5 reverse split of its American Depositary Shares (ADS) to meet Nasdaq's minimum bid price requirement, effective around November 29, 2024.

DBV Technologies announced its third quarter 2024 financial results, reporting a cash balance of $46.4 million and a cash runway extending into the first quarter of 2025.

DBV Technologies has received positive regulatory feedback from the FDA and EMA regarding its Viaskin Peanut patch, paving the way for potential accelerated approval in the US and a marketing authorization application in Europe.

DBV Technologies has successfully completed patient screening for its VITESSE Phase 3 trial of the Viaskin Peanut Patch, evaluating its efficacy in peanut-allergic children aged 4-7 years.

DBV Technologies reports progress on its Viaskin Peanut program, including on-track enrollment for the VITESSE trial and a labeling proposal submitted to the FDA, while also announcing its Q2 2024 financial results.

DBV Technologies has been granted a second extension until December 16, 2024, to regain compliance with Nasdaq's minimum bid price rule and will transfer its listing to the Nasdaq Capital Market.

DBV Technologies has announced a delay in the implementation of its American Depositary Share (ADS) ratio change, now expected to be effective on or about June 7, 2024.