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DBV Technologies SA (DBVT) is a clinical-stage biopharmaceutical leader advancing epicutaneous immunotherapy (EPIT) through its innovative Viaskin platform, targeting food allergies with non-invasive precision. This page aggregates all essential updates on the company’s clinical progress, regulatory milestones, and strategic initiatives.
Investors and stakeholders gain centralized access to critical developments including phase trial results, FDA/EMA interactions, and partnership announcements. Each update is curated to provide actionable insights into DBVT’s pioneering work in allergy treatment while maintaining rigorous scientific accuracy.
Key coverage areas include Viaskin efficacy data, patent developments, and manufacturing scalability updates. The resource is designed to help users track the company’s progress from clinical research to potential commercialization without requiring cross-platform monitoring.
Bookmark this page for streamlined tracking of DBV Technologies’ advancements in redefining food allergy management through its unique skin-based immunotherapy approach.
DBV Technologies (DBVT) has secured FDA agreement that safety exposure data from the VITESSE Phase 3 study will be sufficient for their Biologics License Application (BLA) for Viaskin® peanut patch in children aged 4-7 years with peanut allergy. This eliminates the need for the COMFORT Children supplemental safety study, accelerating the BLA submission timeline to first half of 2026.
The VITESSE study, the largest Phase 3 trial for peanut allergy in this age group with 654 participants, will provide safety data from over 500 participants on active treatment. Topline results are expected in Q4 2025.
The company reported unaudited 2024 financial results with cash and cash equivalents of $32.5 million as of December 31, 2024, down from $141.4 million year-over-year. Operating expenses increased to $120.7 million from $92.2 million in 2023. Net loss widened to $113.9 million ($1.17 per share). Current cash is only sufficient to fund operations into April 2025, raising substantial going concern doubts.
DBV Technologies (DBVT) announced its participation in the AAAAI/WAO Joint Congress from February 28-March 3, 2025, in San Diego. The company will present significant findings from the PEOPLE study, a long-term extension of the Phase 3 PEPITES trial evaluating VIASKIN® peanut patch in peanut-allergic children aged 4-11 years.
Key results at Month 60 show:
- Treatment responders increased to 73.3% (from 39.1% at PEPITES completion)
- 66.7% of participants achieved tolerance to ≥1000 mg peanut protein (equivalent to 3-4 peanut kernels)
- 33.3% reached tolerance to ≥2000 mg peanut protein (6-8 peanut kernels)
- 93.1% treatment compliance rate over five years
Most treatment-related adverse events were mild to moderate local skin reactions, decreasing in frequency over time. The company aims to complete regulatory submissions for two age groups: toddlers (1-3 years) and children (4-7 years).
DBV Technologies (DBVT) has released its Half-Year report on the liquidity contract with ODDO BHF. As of December 31, 2024, the liquidity account held 266,868 DBV Technologies shares and €106,930.51 in cash. This represents a significant change from the contract's implementation on July 1, 2018, which started with 41,159 shares and €432,367.25.
During the period from July 1, 2024, to December 31, 2024, trading activity included 1,682 buy transactions and 1,800 sales transactions. The total volume traded comprised 404,081 shares (€296,390.97) in purchases and 440,957 shares (€340,906.76) in sales.
DBV Technologies (DBVT) has announced positive three-year results from the EPITOPE Phase 3 Open-Label Extension Study for its VIASKIN® Peanut patch treatment in toddlers aged 1-3 years. After 36 months of treatment, 83.5% of participants reached an eliciting dose of ≥1000 mg, up from 64.2% at month 12. 68.2% of subjects completed the oral food challenge without meeting stopping criteria, compared to 30.7% at month 12.
The study showed continued improvement in efficacy with no treatment-related anaphylaxis or serious treatment-related adverse events in year three. New data analysis revealed that subjects with average daily wear time (ADWT) ≥20 hours showed better efficacy response (75.7%) compared to those with <20 hours (47.3%). The company also reported that 68.4% of participants maintained an ADWT ≥20 hours, demonstrating strong correlation between wear time and treatment effectiveness.
DBV Technologies has secured FDA alignment on an Accelerated Approval pathway for the Viaskin® Peanut patch in toddlers aged 1-3 years. The FDA confirmed that efficacy data from the Phase 3 EPITOPE study can serve as an intermediate clinical endpoint for approval. The company plans to initiate the COMFORT Toddlers study in Q2 2025, enrolling approximately 480 subjects across multiple countries.
The COMFORT Toddlers study will be a six-month double-blind, placebo-controlled trial followed by an optional 18-month open-label treatment phase. DBV anticipates submitting a Biologics License Application (BLA) for the toddler indication in the second half of 2026. The FDA has also agreed on criteria for a post-marketing confirmatory study, which will need to be initiated at the time of BLA submission.
DBV Technologies has reported its voting rights and share count as of November 30, 2024. The company's total number of shares stands at 102,847,501. The gross voting rights total 102,847,501, while the net voting rights amount to 102,582,335. The difference between gross and net voting rights (265,166) represents shares without voting rights. The company's shares are listed on NYSE Euronext Paris under the ISIN Code FR 0010417345.
DBV Technologies has announced plans to change its American Depositary Shares (ADS) ratio from 1:1 to 1:5, effective around November 29, 2024. This change will function like a one-for-five reverse ADS split, aimed at regaining compliance with Nasdaq's minimum bid price requirement. ADS holders with certificated shares must surrender them for cancellation and will receive one new ADS for every five existing ones. Uncertificated ADS holders in DRS and DTC will have automatic exchanges. The company's ADSs will continue trading under 'DBVT' on Nasdaq. Fractional ADSs will be sold, with proceeds distributed to holders. The change won't affect underlying ordinary shares.
DBV Technologies reported Q3 2024 financial results with a cash balance of $46.4 million, down from $141.4 million at end of 2023. The company reported a net loss of $90.9 million for the first nine months of 2024, compared to $61.5 million in the same period of 2023. Operating expenses increased to $96.4 million, primarily due to research and development costs for the VITESSE Phase 3 clinical trial. The company's cash runway extends into Q1 2025, but there is substantial doubt about its ability to continue as a going concern without additional capital.
DBV Technologies (DBVT) announced positive regulatory updates for the Viaskin® Peanut patch in the US and Europe. The company will pursue an Accelerated Approval pathway for toddlers ages 1-3 years old, subject to completing a six-month supplemental safety study (COMFORT Toddlers) in Q2 2025. The VITESSE Phase 3 study for children ages 4-7 exceeded enrollment goals, with topline results expected in Q4 2025.
The European Medicines Agency (EMA) confirmed a registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1-7 year-old indication in Europe. DBV plans to formalize the FDA guidance via a meeting request. The company's cash and cash equivalents amounted to $46.4 million as of September 30, 2024, with funding projected to last into Q1 2025.
DBV Technologies (Nasdaq: DBVT) announced its participation in the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting from October 24-28, 2024, in Boston. The company will feature a 'Product Theater' panel discussion on 'What Defines an Optimal Peanut Allergy Treatment?' on October 26th. DBV is also sponsoring the 33rd Annual FIT Bowl and will host a booth in the ACAAI Exhibit Hall.
Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies, highlighted the company's recent completion of enrollment for the VITESSE study in children 4-7 years old. DBV continues to advance regulatory progress with the Viaskin® peanut patch for 1-3-year-olds and 4-7-year-olds. The Viaskin Peanut patch is DBV's lead product candidate designed to reduce the risk of allergic reactions due to accidental peanut exposure through an investigational, non-invasive, once-daily epicutaneous patch.
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