Core Insights - DBV Technologies announced positive top line results from its Phase III VITESSE clinical trial of the VIASKIN Peanut patch for children aged 4 to 7 years old [1] Group 1: Clinical Trial Results - The Phase III VITESSE clinical trial demonstrated positive outcomes for the VIASKIN Peanut patch [1] Group 2: Forward-Looking Statements - The company may discuss the therapeutic potential of VIASKIN Peanut and its clinical and regulatory development plans [2] - Anticipated interactions with regulatory agencies and plans for the submission of Biologics License Applications (BLAs) to the FDA are highlighted [2] - Expectations regarding the BLA's potential eligibility for priority review and support for the submission are mentioned [2]

DBV Technologies (NasdaqCM:DBVT) Update / Briefing December 16, 2025 05:00 PM ET Company ParticipantsPharis Mohideen - Chief Medical OfficerJonathan Neely - Head of Investor RelationsDaniel Tassé - CEOKevin Trapp - Chief Commercial OfficerConference Call ParticipantsAbby Gray - AnalystKristen Kluska - AnalystJon Wolleben - AnalystYatin Suneja - AnalystSam Slutsky - AnalystSushila Hernandez - AnalystOperatorWelcome to the DBV Technologies Update conference call. All participants will be in a listen-only mode ...

Clinical Trial Results - DBV's experimental skin patch showed positive results in a crucial study for young children with peanut allergy [1]

Châtillon, France, December 16, 2025 DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years VITESSE met its primary endpoint: the lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15% 46.6% of children treated with the VIASKIN® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm Sa ...

Group 1 - DBV Technologies S.A. (DBVT) is highlighted as a company with limited coverage from Wall Street, indicating potential investment opportunities due to its under-the-radar status [2] - The company is preparing to file a key marketing application in the near future, which could be a significant catalyst for its stock performance [2] - The Biotech Forum, led by an experienced market analyst, offers a model portfolio featuring 12-20 high upside biotech stocks, suggesting a focus on high beta sectors with substantial investor returns [2]

Core Insights - U.S. stocks exhibited mixed performance, with the Nasdaq Composite declining by over 100 points on Wednesday [1] - Daktronics, Inc. reported quarterly earnings of 35 cents per share, surpassing the analyst consensus estimate of 27 cents per share, and quarterly sales of $229.253 million, exceeding the consensus estimate of $214.077 million [1] Company Performance - Daktronics shares surged by 15.7% to $20.80 following the positive earnings report [2] - Photronics, Inc. saw its shares increase by 44% to $37.00 after reporting better-than-expected fourth-quarter results and issuing optimistic first-quarter guidance [3] - Nextdoor Holdings, Inc. gained 24.6% to $2.5050 after a positive social media mention regarding its valuation [3] - Braze, Inc. rose by 17.5% to $36.00 after raising its FY2026 adjusted EPS and sales guidance [3] - Dave & Buster's Entertainment, Inc. jumped 14% to $20.50 following its third-quarter results [3] - SuperX AI Technology Limited's shares increased by 13.8% to $19.63 [3] - GE Vernova Inc. rose by 11.8% to $699.59 after raising its FY28 outlook and dividend, along with expanding its buyback authorization [3] - DBV Technologies S.A. gained 11.2% to $19.09 [3] - Warby Parker Inc. rose by 11% to $25.77 [3] - Dyne Therapeutics, Inc. increased by 10.5% to $20.38 after announcing a $350 million public offering [3] - ABIVAX Société Anonyme rose by 8.6% to $133.24 [3] - Olema Pharmaceuticals, Inc. gained 8.1% to $28.67 [3] - The Middleby Corporation rose by 6.3% to $137.15 after an upgrade from Jefferies [3] - EchoStar Corporation increased by 5.6% to $98.80 following an upgrade from Morgan Stanley [3]

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]

Summary of DBV Technologies FY Conference Call Company Overview - **Company**: DBV Technologies (NasdaqCM:DBVT) - **Industry**: Biotech, specifically focusing on food allergies - **Key Executives Present**: - Daniel Tassé (CEO) - Faris Mohideen (Chief Medical Officer) - Kevin Trapp (Chief Commercialization Officer) Core Points and Arguments - **Market Need**: - An estimated 17-33 million Americans suffer from food allergies, with 700,000 children affected by peanut allergies alone [2][2] - There is a significant unmet medical need in the food allergy space, driving interest and investment in biotech [2][2] - **Technology and Product**: - DBV's lead product utilizes a novel patch technology for epicutaneous immunotherapy (EPIT) called ViaSkin, specifically targeting peanut allergies in children [3][3] - The company has two parallel programs targeting different age groups: children aged 1-4 and 4-7, with distinct patches for each group [5][5] - **Regulatory Pathway**: - The company plans to file a Biologics License Application (BLA) for the 4-7 age group in the first half of 2026 and for the 1-3 age group in the latter half of 2024 [6][6][56][56] - The VITESSE trial for the 4-7 age group is the largest study of its kind, with 654 randomized subjects [9][9] - **Study Endpoints**: - The primary endpoint for the VITESSE trial requires a 15% lower bound confidence interval difference between active and placebo groups [11][11] - Previous studies indicated a response rate of approximately 34%-35% in the targeted age group, with conservative estimates for the VITESSE study set at a 28% delta [20][20][23][23] - **Safety Profile**: - The safety profile of the patch has been characterized well, with high compliance rates (over 98%) and minimal discontinuation due to side effects [61][61] - Local application site reactions are the most common side effect, which tend to decrease in frequency and severity over time [61][61] Market Opportunity - **Target Population**: - The 4-7 age group represents approximately 400,000 patients, with a significant opportunity to shift from avoidance and epinephrine to treatment [35][35] - The company aims to engage with around 4,500 allergists at launch, supported by a small sales force of about 70 representatives [35][35] - **Pricing Strategy**: - The pricing is expected to be in the range of $10,000 net, similar to existing therapies like Palforzia [41][41] - There is a strong interest from parents for a non-invasive treatment option that retrains the immune system [41][41] Financial Position - **Cash Position**: - DBV Technologies has sufficient cash to operate until the end of 2026, with potential additional capital from the exercise of warrants linked to the VITESSE trial results [67][67] - The successful readout of the VITESSE data could trigger $181 million in additional funding if the primary endpoint is met [67][67] Additional Considerations - **Regulatory Environment**: - The FDA has shown a positive stance towards food allergy treatments, facilitating a productive dialogue with DBV Technologies [44][44][45][45] - **Future Studies**: - A new study is planned to assess the long-term benefits of treatment in younger children, which will begin rolling out next year [59][59] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic direction, product development, market potential, and financial outlook.

Core Insights - DBV Technologies will participate in the Guggenheim 2 Annual Healthcare Innovation Conference on November 11, where CEO Daniel Tassé will engage in a fireside chat [1] - A live webcast of the event will be available, along with an archived replay for 90 days [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 [3] - The company is investigating its proprietary VIASKIN® patch technology, which aims to treat food allergies through epicutaneous immunotherapy (EPIT) [3] - The VIASKIN® patch introduces microgram amounts of biologically active compounds to the immune system via intact skin, aiming to desensitize individuals to allergens [3] - Current clinical trials include the VIASKIN Peanut for peanut allergic toddlers aged 1 to 3 years and children aged 4 to 7 years [3] - DBV Technologies is headquartered in Châtillon, France, with operations in Warren, NJ, and its shares are traded on Euronext Paris and the Nasdaq Capital Market [4]

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]