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DBV Technologies to Join CAC Mid 60 and SBF 120 Indices Following Euronext Paris Annual Review
Globenewswire· 2026-03-24 20:30
Châtillon, France, March 24, 2026 DBV Technologies to Join CAC Mid 60 and SBF 120 Indices Following Euronext Paris Annual Review Changes went into effect on Monday, March 23, 2026 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today announced that following the annual review of the Euronext Paris indices on March 12, 2026, the Scientific Council of the Indices has admitted DBV to the CAC Mid 60 and SBF 120 Indices. The changes wen ...
DBV Technologies (NasdaqCM:DBVT) 2026 Conference Transcript
2026-03-10 18:42
Summary of DBV Technologies Conference Call Company Overview - **Company**: DBV Technologies - **Industry**: Biotechnology, specifically focused on food allergies - **Product**: Viaskin, a platform for epicutaneous immunotherapy targeting food allergies, primarily peanut allergy [4][5] Core Points and Arguments - **Market Need**: Food allergies, particularly peanut allergies, represent a significant unmet medical need with high healthcare costs and life-threatening reactions. 80% of patients do not outgrow peanut allergies [4][5] - **Regulatory Path**: DBV plans to submit two Biologics License Applications (BLAs) in 2026: one for children aged 4-7 and another for 1-3 years old. The first submission is expected in the first half of 2026 [5][9][10] - **Clinical Data**: Over 1,600 patients have been treated with Viaskin Peanut, showing a 47% responder rate in the active arm compared to 15% in placebo during the VITESSE study. The treatment effect improves over time, with ongoing studies showing positive results [20][21][35] - **Safety Profile**: The treatment has a low anaphylaxis rate of 0.5%, with mild to moderate local site reactions that typically resolve within months [35] Development Strategy - **Age Group Focus**: The separation of BLAs for different age groups is seen as advantageous, allowing for two distinct market opportunities. The company emphasizes the importance of early treatment for better desensitization outcomes [8][10] - **Clinical Milestones**: A rich agenda of clinical milestones is planned over the next 18 months, including BLA submissions and study completions [9][10] Market Dynamics - **Prevalence**: Approximately 670,000 children aged 1-7 are affected by peanut allergies, with only 20% expected to outgrow them. The majority are currently managing their allergies through avoidance and epinephrine use [41][43] - **Competitive Landscape**: The launch of Xolair has increased interest in food allergies, but DBV's approach is differentiated as it focuses on desensitization rather than IgE suppression [46][48] Future Pipeline - **Next Product**: Following Viaskin Peanut, DBV plans to develop a treatment for cow's milk protein allergies, which is also a significant opportunity in the market [80][81] Financial Considerations - **Funding**: DBV has EUR 300 million in cash, sufficient to fund operations through the launch of the 4-7 year old product. The company is focused on building a commercial team and inventory for the launch [89][90] Communication Strategy - **Target Audience**: The company plans to educate both parents and allergists about the benefits of Viaskin, emphasizing risk reduction and the potential for improved quality of life for children with food allergies [25][26][41] Conclusion DBV Technologies is positioned to address a significant unmet need in the food allergy market with its innovative Viaskin platform. The company is on track for regulatory submissions and has a clear strategy for market entry and future product development.
DBV Technologies S.A. (DBVT) Presents at American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting - Slideshow (NASDAQ:DBVT) 2026-03-04
Seeking Alpha· 2026-03-04 23:28
Core Insights - The company is focused on the development of transcript-related projects, indicating a commitment to enhancing its offerings in this area [1] Group 1 - The company publishes thousands of quarterly earnings calls each quarter, showcasing its extensive coverage and growth in the transcript market [1] - There is an ongoing effort to expand coverage, suggesting potential for increased market share and user engagement in the future [1]
DBV Technologies to Participate in Upcoming March Investor Conferences
Globenewswire· 2026-03-04 21:30
Company Overview - DBV Technologies is a late-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions with significant unmet medical needs [3]. - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ [4]. - DBV Technologies' ordinary shares are traded on Euronext Paris and its American Depositary Shares (ADSs) are traded on the Nasdaq Capital Market [4]. Product Development - The company is investigating the use of its proprietary VIASKIN patch technology to address food allergies, which are caused by hypersensitive immune reactions [3]. - VIASKIN patch utilizes epicutaneous immunotherapy (EPIT) to introduce microgram amounts of biologically active compounds to the immune system through intact skin, aiming to modify the underlying allergy by re-educating the immune system [3]. - Ongoing clinical trials include the VIASKIN Peanut program targeting peanut allergic toddlers (1-3 years) and children (4-7 years) [3]. Upcoming Events - DBV Technologies will participate in the Citizens Life Sciences Conference on March 10, 2026, featuring a fireside chat at 1:40 PM ET [1]. - The company will also attend the Leerink Partners Global Healthcare Conference on March 11, 2026, with a format of one-on-one meetings [2].
DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting
Globenewswire· 2026-02-28 19:25
Core Insights - DBV Technologies presented additional positive data from the Phase 3 VITESSE clinical trial for the VIASKIN Peanut Patch at the AAAAI 2026 Annual Meeting, indicating its potential as a treatment for peanut allergies in children aged 4 to 7 years [2][5] Study Results - The VITESSE study met its primary endpoint, showing a statistically significant treatment effect (p<0.001), with 46.6% of children in the VIASKIN Peanut group meeting treatment responder criteria at 12 months, compared to 14.8% in the placebo group, resulting in a difference of 31.8% [3][6] - Approximately 83% of children treated with the VIASKIN Peanut Patch increased their eliciting dose at month 12, compared to 48% in the placebo group [6][7] - 60% of children treated with the VIASKIN Peanut Patch increased their eliciting dose by at least two doses at month 12, compared to 23% in the placebo group [6][7] - 24% of children on placebo decreased their eliciting dose, while only 6.4% of those treated with the VIASKIN Peanut Patch experienced a decrease [6][7] Treatment Effectiveness - The data suggest a broad and consistent treatment effect of the VIASKIN Peanut Patch across different baseline eliciting dose strata and study population analyses [5] - Among children with a baseline eliciting dose (ED) ≤30 mg, 49.3% were responders versus 14.7% in the placebo group, and among those with a baseline ED = 100 mg, 43.1% were responders versus 14.6% in the placebo group [7] Safety Profile - The VIASKIN Peanut Patch was well tolerated, with most treatment-emergent adverse events being mild local reactions, consistent with previous Phase 3 studies [7] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) to the FDA in the first half of the year, supported by the positive data from the VITESSE study [8]
DBV Technologies (NasdaqCM:DBVT) 2026 Conference Transcript
2026-02-12 20:32
Summary of DBV Technologies Conference Call Company Overview - **Company**: DBV Technologies (NasdaqCM:DBVT) - **Focus**: Immunology, specifically food allergies in children - **Lead Product**: Viaskin Peanut, aimed at treating peanut allergies in children aged 1-7 Key Points Product Development and Regulatory Filings - **BLA Filings**: Two Biologics License Applications (BLAs) are planned for 2026: - **Children aged 4-7**: Expected filing by mid-2026 - **Children aged 1-3**: Expected filing by the end of 2026 - **FDA Designation**: The product has received breakthrough designation from the FDA and will seek priority review for the first filing [1][2][3] Market Opportunity - **Prevalence of Food Allergies**: Approximately 670,000 children in the U.S. have diagnosed peanut allergies: - 390,000 children aged 4-7 - 280,000 children aged 1-3 - **Response Rates**: In the 1-3 age group, the response rate was 67% for active treatment compared to 33.5% for placebo, with a 22.4% delta [24][25] Clinical Trial Insights - **VITESSE Trial**: The largest trial for peanut allergy with 654 patients, showing a placebo-adjusted efficacy of 32 points [13][14] - **Long-term Benefits**: Open-label extensions indicate improved efficacy and safety over time, with 68% of children in the 1-3 age group able to consume significant amounts of peanuts without anaphylaxis after three years of treatment [25][26] Competitive Landscape - **Comparison with IgE Blockade**: DBV Technologies focuses on desensitization, which is seen as disease-modifying, while IgE blockade is viewed as a temporary solution [5][7][58] - **Palforzia Comparison**: DBV believes Viaskin Peanut is superior due to its ease of use and lower risk of anaphylaxis compared to Palforzia, which requires frequent physician visits and has a higher rate of anaphylaxis during treatment [63][64] Commercial Strategy - **Target Audience**: Approximately 4,500 allergists and immunologists in the U.S. will be targeted for prescribing [43] - **Sales Force**: Estimated need for 50-70 sales representatives to reach the target audience effectively [46] - **Pricing Strategy**: While no final price has been set, Palforzia's pricing at around $1,000 per month is considered a reference point [47][48] Future Directions - **Expansion Plans**: After the approval of Viaskin Peanut, the company plans to pursue other allergies, with cow's milk allergy as the next target [82] - **Manufacturing Capacity**: Current manufacturing is sufficient for initial launch, but plans to triple capacity in the coming years are in place [83] Financial Position - **Funding**: As of Q3, the company has $320 million, which is deemed sufficient to support the launch in 2027 and necessary investments [88][91] Additional Insights - **Engagement with Families**: The company emphasizes the importance of communication with families and patient advocacy groups, as parents of children with food allergies are highly engaged [46] - **Safety Profile**: The Viaskin Peanut patch has shown no severe adverse events in clinical studies, which may lead to a cleaner label compared to other treatments [74][75] This summary encapsulates the critical aspects of DBV Technologies' conference call, highlighting the company's strategic direction, product development, market potential, and competitive positioning in the food allergy treatment landscape.
DBV Technologies to Present Additional Data from the VITESSE Phase 3 Study of the VIASKIN® Peanut Patch in Children Ages 4-7 Years and Discuss Future of EPIT in the Treatment Landscape at AAAAI 2026 Annual Meeting
Globenewswire· 2026-02-10 21:30
Core Insights - DBV Technologies will present additional data from the VITESSE Phase 3 study of the VIASKIN® Peanut Patch for children aged 4-7 at the AAAAI 2026 Annual Meeting in Philadelphia from February 27 to March 2, 2026 [1] - The company will host a product theater featuring allergists discussing the potential of epicutaneous immunotherapy (EPIT) in food allergy treatment and the impact of early intervention [2] Company Overview - DBV Technologies is a late-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions with significant unmet medical needs [4] - The company is investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which can cause severe reactions including anaphylaxis [4] - The VIASKIN® patch aims to introduce microgram amounts of biologically active compounds to the immune system through intact skin, representing a non-invasive treatment approach [4] Event Details - The oral abstract presentation titled "VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children 4 Through 7 Years of Age" will take place on February 28, 2026 [3][6] - The product theater session titled "Epicutaneous Immunotherapy (EPIT): Shaping the Future of Pediatric Food Allergy Treatment" will also occur on February 28, 2026 [3][6] - DBV will exhibit at booth 1527 at the AAAAI exhibit hall to provide more information about epicutaneous immunotherapy and the VIASKIN® Peanut Patch [3]
DBV Technologies to Participate in the Guggenheim Securities Emerging Outlook: Biotech Summit
Globenewswire· 2026-02-09 21:30
Core Insights - DBV Technologies, a late-stage biopharmaceutical company, will participate in the Guggenheim Securities Emerging Outlook: Biotech Summit on February 11-12, 2026, with CEO Daniel Tassé scheduled to present on February 12 at 2:30 PM ET [1] Company Overview - DBV Technologies is focused on developing treatment options for food allergies and other immunologic conditions, utilizing its proprietary VIASKIN® patch technology [3] - The company aims to address food allergies through epicutaneous immunotherapy (EPIT), which introduces microgram amounts of biologically active compounds to the immune system via intact skin [3] - DBV's food allergy programs include ongoing clinical trials of VIASKIN® Peanut for peanut allergic toddlers (1-3 years) and children (4-7 years) [3] Operations and Trading - DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ [4] - The company's ordinary shares are traded on segment B of Euronext Paris and its American Depositary Shares (ADSs) are traded on the Nasdaq Capital Market [4]
DBV Technologies Announces €166.7 Million in Gross Proceeds Following the Full Exercise of the ABSA Warrants and BS Warrants Issued on its March 2025 Financing
Globenewswire· 2026-01-16 23:11
Core Viewpoint - DBV Technologies has successfully raised €166.7 million through the full exercise of ABSA and BS Warrants, which will support the launch of the VIASKIN® Peanut patch for children aged 4 to 7 years in the U.S., pending approval [1][11]. Financing Details - The financing involved the issuance of 34,090,004 ABSA Warrants and 71,005,656 BS Warrants, leading to the issuance of 59,657,507 new ordinary shares and up to 124,259,898 pre-funded warrants [1][5]. - The exercise price for the ABSA Warrants was €1.5939, while the BS Warrants had an exercise price of €1.5764 [1][6]. Use of Proceeds - The gross proceeds from the exercise will be utilized for working capital, general corporate purposes, and to finance the preparation and submission of a potential Biologics License Application (BLA) for the VIASKIN® Peanut patch [10][11]. - The total financing, including potential exercises of outstanding warrants, is estimated to reach approximately €284.5 million [10]. Shareholder Impact - The issuance of new shares will dilute existing shareholders' equity, with ownership interest for a shareholder holding 1.00% of the Company's share capital decreasing to 0.78% on a non-diluted basis after the issuance [15]. - The shareholding structure will change post-issuance, with Baker Brothers Investments retaining 8.64% and Janus Henderson acquiring 7.54% of the diluted share capital [17]. Company Overview - DBV Technologies is a late-stage biopharmaceutical company focused on developing treatments for food allergies using its proprietary VIASKIN® patch technology [19]. - The company is headquartered in Châtillon, France, with operations in North America [20].
Information Regarding the Total number of Voting Rights and Total Number of Shares of the Company as of December 31, 2025
Globenewswire· 2026-01-12 21:00
Group 1 - The document provides updated information regarding the total number of voting rights and shares of the company as of December 31, 2025, replacing previous information published on January 5, 2026 [1] - The total number of shares as of December 31, 2025, is 235,670,864, which is also the total number of voting rights [2] - The net total of voting rights, which excludes shares without voting rights, is 235,596,284 [2]