Epicutaneous immunotherapy (EPIT)
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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 Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years
Globenewswire· 2025-12-16 21:05
Core Insights - DBV Technologies announced positive topline results from the Phase 3 VITESSE trial for the VIASKIN Peanut patch, which met its primary endpoint for treating peanut-allergic children aged 4-7 years [1][6] Study Results - VIASKIN Peanut showed a statistically significant treatment effect with 46.6% of children in the treatment group meeting responder criteria after 12 months, compared to 14.8% in the placebo group, resulting in a difference of 31.8% [2][6] - Responders were defined as children who increased their eliciting dose (ED) of peanut protein significantly after treatment, with specific thresholds based on their baseline ED [3] Safety Profile - The safety results were consistent with previous studies, with mild-to-moderate local skin reactions being the most common adverse events; discontinuation due to adverse events was low at 3.2% in the treatment arm [5][6] - No treatment-related serious adverse events were reported, and treatment-related anaphylaxis was low at 0.5% [5] Enrollment and Study Design - The VITESSE study enrolled 654 children, exceeding the target of 600, with a balanced distribution between active and placebo arms [4][6] - The study is noted as the largest immunotherapy clinical trial for food allergies, conducted at 86 sites across multiple countries [16] Future Plans - DBV Technologies plans to submit a Biologics License Application (BLA) for the VIASKIN Peanut patch in the first half of 2026 [6][7] - The achievement of the primary endpoint will accelerate the exercise period of certain warrants issued in connection with a financing announced in March 2025 [6][11] Industry Context - The VIASKIN patch represents a new class of non-invasive treatment aimed at modifying the immune response to food allergens, addressing a significant unmet medical need in pediatric care [12][14]
DBV Technologies Announces Last Patient Visit Completed in VITESSE Phase 3 Clinical Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years
Globenewswire· 2025-11-12 04:50
Core Insights - DBV Technologies has completed the last patient visit in the Phase 3 VITESSE clinical trial for the VIASKIN Peanut patch aimed at peanut allergic children aged 4-7 years, with topline data expected in Q4 of this year [1][2][3] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions, utilizing its proprietary VIASKIN patch technology [4] - 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 [4] Clinical Trial Details - The VITESSE Phase 3 trial involves 654 subjects aged 4-7 years, randomized in a 2:1 ratio, and is conducted across 86 sites in the U.S., Canada, Europe, the UK, and Australia, making it the largest treatment intervention study for peanut allergy [3] - The trial evaluates the efficacy and safety of the VIASKIN Peanut patch over a 12-month period [3] Future Outlook - The completion of the last patient visit is considered a significant milestone for the company, moving closer to potentially providing a treatment option for peanut allergic children if approved [3]
DBV Technologies Appoints Industry Leader Kevin Trapp as Chief Commercial Officer
Globenewswire· 2025-11-03 21:30
Core Insights - DBV Technologies has appointed Kevin Trapp as Chief Commercial Officer to lead global commercial strategy for the Viaskin® Peanut patch [1][2] - The company plans to submit a Biologics License Application (BLA) for children aged 4-7 with peanut allergies in the first half of 2026, followed by a submission for 1-3 year-olds in the second half of the same year [1][2] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions with significant unmet medical needs [4] - The company utilizes its proprietary VIASKIN® patch technology to address food allergies through epicutaneous immunotherapy (EPIT), which aims to desensitize the immune system to allergens [4] Leadership Background - Kevin Trapp has over 30 years of experience in the biopharmaceutical industry and has been involved with DBV's commercial strategy since 2017 [2][3] - Prior to rejoining DBV, Trapp served as Managing Director at Biotech Value Advisors, advising biotechnology companies on product strategy and launch planning [2][3] Product Development - The Viaskin Peanut patch aims to provide a new treatment option for families living with food allergies, addressing an urgent medical need [3][4] - DBV Technologies is currently conducting clinical trials for the VIASKIN Peanut patch in toddlers and children with peanut allergies [4]
DBV Technologies Announces Appointment of Philina Lee, Ph.D. to Board of Directors
Globenewswire· 2025-10-30 20:30
Core Points - DBV Technologies has appointed Dr. Philina Lee as an independent director to its Board of Directors, effective October 30, 2025, replacing Daniel Soland, pending shareholder ratification [1][2] - Dr. Lee brings extensive experience in the biopharmaceutical sector, having previously served as Chief Commercial Officer at Blueprint Medicines, where she led the successful launch of AYVAKIT® [2] - The company is focused on advancing its proprietary VIASKIN® Peanut patch technology for treating peanut allergies in children and toddlers, with ongoing clinical trials [3][4] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company headquartered in Châtillon, France, with operations in Warren, NJ, specializing in treatments for food allergies and other immunologic conditions [4] - The company is committed to transforming care for individuals with food allergies through its epicutaneous immunotherapy (EPIT) approach, which aims to desensitize the immune system to allergens [3]
DBV Technologies Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-10-28 20:25
Core Insights - DBV Technologies reported a net loss of $102.1 million for the nine months ended September 30, 2025, compared to a net loss of $90.9 million for the same period in 2024, with a net loss per share of $0.82 [7][8][25] - The company ended Q3 2025 with cash and cash equivalents of $69.8 million, a significant increase from $32.5 million at the end of 2024, providing a cash runway into the third quarter of 2026 [9][13] - Operating expenses rose to $107.0 million for the nine months ended September 30, 2025, up from $96.4 million in the same period of 2024, primarily due to the launch of the COMFORT Toddlers supplemental safety study [5][6] Financial Highlights - Research tax credits increased to $5.0 million for the nine months ended September 30, 2025, compared to $3.6 million in 2024, reflecting more eligible activities [4] - Operating income for the nine months ended September 30, 2025, was $5.0 million, up from $3.6 million in 2024 [4] - Total liabilities increased to $57.6 million as of September 30, 2025, from $38.3 million at the end of 2024 [23] Cash Flow and Financing - Net cash flow used in operating activities decreased to $86.0 million for the nine months ended September 30, 2025, from $92.2 million in 2024, indicating improved cost management [20] - The company raised $117.1 million from financing activities during the nine months ended September 30, 2025, compared to a negligible amount in the same period of 2024 [22] - DBV Technologies established an equity offering program with an aggregate offering price of up to $150.0 million, and subsequently raised approximately $30 million from the issuance of shares [12] Business Overview - DBV Technologies focuses on developing treatment options for food allergies using its proprietary VIASKIN® patch technology, which aims to modify the immune response to allergens [26] - The company is currently conducting clinical trials for the VIASKIN Peanut patch in young children with peanut allergies [26] - DBV Technologies is headquartered in Châtillon, France, with operations in North America [27]
DBV Technologies Announces Sale of approximately $30 million of ADSs Through its At-The-Market (ATM) Program on Nasdaq
Globenewswire· 2025-10-06 21:02
Core Viewpoint - DBV Technologies has announced the sale of approximately $30 million of American Depositary Shares (ADSs) through its At-The-Market (ATM) program on Nasdaq, aimed at raising funds for its clinical-stage biopharmaceutical operations [1][2]. Group 1: Financial Details - The company will issue 11,538,460 new Ordinary Shares, equivalent to 2,307,692 new ADSs, at an at-the-market price of $13.00 per ADS, resulting in gross proceeds of approximately $30 million before expenses [2]. - The issuance price per Ordinary Share is €2.2264, based on the USD/EUR exchange rate of $1.1678 for €1, reflecting a discount of 3.41% to the last closing price on Euronext Paris [2]. - The new Ordinary Shares will represent 8.42% of the existing shares on Euronext Paris, with a dilution effect of approximately 7.77% upon completion of the transaction [3][4]. Group 2: Regulatory and Market Information - The new ADSs will be admitted to trading on Nasdaq, while the new Ordinary Shares will be listed on Euronext Paris [3]. - The share capital increase is exempt from the requirement of a prospectus approval by the French Financial Markets Authority, as it is offered to qualified investors and represents less than 30% of the existing shares over a rolling 12-month period [6][12]. Group 3: Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions, utilizing its proprietary Viaskin technology platform [12][13]. - The company is currently conducting clinical trials for its Viaskin Peanut product aimed at treating peanut allergies in young children [12].
DBV Technologies Announces Sale of approximately $30 million of ADSs Through its At-The-Market (ATM) Program on Nasdaq
Globenewswire· 2025-10-06 21:02
Core Viewpoint - DBV Technologies has announced the sale of approximately $30 million of American Depositary Shares (ADSs) through its At-The-Market (ATM) program on Nasdaq, which will involve the issuance of new ordinary shares [1][2]. Group 1: Financial Details - The ATM program will issue 11,538,460 new ordinary shares, equivalent to 2,307,692 new ADSs, at an at-the-market price of $13.00 per ADS, resulting in gross proceeds of approximately $30 million before expenses [2]. - The issuance price per ordinary share is €2.2264, based on the USD/EUR exchange rate of $1.1678 for €1, reflecting a discount of 3.41% to the last closing price of the company's shares on Euronext Paris [2]. - The new ordinary shares will represent 8.42% of the existing shares on Euronext Paris, with a dilution of approximately 7.77% upon completion of the transaction [3][4]. Group 2: Regulatory and Market Information - The new ordinary shares will be admitted to trading on Nasdaq and Euronext Paris, with the issuance expected to take place on October 8, 2025 [3]. - A shelf registration statement on Form S-3 relating to the ADSs has been filed with the SEC and declared effective, allowing for the offering without the need for a prospectus approval from the French Financial Markets Authority [5][6]. - The share capital structure before and after the ATM issuance shows a change in ownership percentages among major shareholders, with Invus increasing its stake significantly [7][8]. Group 3: Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions, utilizing its proprietary Viaskin technology platform [12]. - The company is currently conducting clinical trials for its Viaskin Peanut product aimed at treating peanut allergies in young children [12][13].
DBV Technologies Announces Resignation of Board Member
Globenewswire· 2025-09-18 20:30
Core Viewpoint - DBV Technologies announced the resignation of Daniel Soland from its Board of Directors, effective immediately, and expressed gratitude for his contributions since 2015 [1][2]. Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions with significant unmet medical needs [3]. - The company is investigating its proprietary VIASKIN® patch technology, which aims to address food allergies through epicutaneous immunotherapy (EPIT) [3]. - The VIASKIN® patch is designed to introduce microgram amounts of biologically active compounds to the immune system via intact skin, aiming to modify the underlying allergy and desensitize the immune system [3]. Current Operations - DBV Technologies is conducting ongoing clinical trials of the VIASKIN Peanut patch for peanut allergic toddlers (ages 1 to 3) and children (ages 4 to 7) [3]. - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ [4]. - The ordinary shares of DBV Technologies are traded on segment B of Euronext Paris, and its American Depositary Shares (ADSs) are traded on the Nasdaq Capital Market [4].