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- DBV Technologies filed its 2026 Half-Year Report with the French market authority (AMF) for the semester ended June 30, 2026. - The company will host a conference call and live webcast on July 16, 2026, at 5:00 p.m. ET to review second quarter 2026 financial results and provide a business update. - DBV Technologies is a late-stage biopharmaceutical company developing the VIASKIN® patch for food allergies, with ongoing trials in peanut-allergic toddlers and children. - The VIASKIN® patch uses epicutaneous immunotherapy (EPIT), a non-invasive approach designed to desensitize the immune system to allergens through intact skin.
- DBV Technologies filed a new shelf registration with the SEC to renew its at-the-market (ATM) offering program for up to $150 million in American Depositary Shares. - Net proceeds will primarily fund manufacturing capacity expansion, BLA submissions for VIASKIN® Peanut in children aged 1–3 and 4–7 years, and pre-launch preparations for the 4–7 age group. - The ATM program operates under a sales agreement with Citizens JMP Securities as placement agent, with terms and conditions remaining unchanged from the original September 2025 agreement. - DBV Technologies is an advanced-stage biopharmaceutical company developing epicutaneous immunotherapy (EPIT) via its VIASKIN® platform for food allergies, a condition affecting millions including young children.
- DBV Technologies has completed the last patient visit in its Phase 3 VITESSE clinical trial evaluating the VIASKIN Peanut patch in 654 peanut-allergic children aged 4-7 years. - The 12-month, double-blind, placebo-controlled study represents the largest treatment intervention study in peanut allergy, conducted across 86 sites in multiple countries. - The company remains on track to announce topline data from the trial in the fourth quarter of this year, marking a critical milestone for the epicutaneous immunotherapy approach. - VIASKIN patch technology delivers microgram amounts of allergen through intact skin to re-educate the immune system and reduce allergic reactions.
- DBV Technologies has appointed Kevin Trapp as Chief Commercial Officer to lead global commercial strategy for the Viaskin Peanut patch ahead of anticipated regulatory submissions. - The company expects to submit a Biologics License Application for children aged 4-7 years with peanut allergy in the first half of 2026, followed by a submission for 1-3 year-olds later that year. - Trapp brings over 30 years of biopharmaceutical experience, including managing a $4 billion portfolio at Bristol-Myers Squibb and overseeing launches of more than 10 products. - The appointment comes as DBV anticipates VITESSE Phase 3 topline results for the Viaskin Peanut patch in the fourth quarter of 2025.
- DBV Technologies initiated a $150 million At-The-Market offering in September 2025 to fund Biologics License Applications for its VIASKIN Peanut patch, targeting both 4-7-year-olds and 1-3-year-old toddlers. - The FDA has agreed that VITESSE Phase 3 trial data alone will support the BLA filing for 4-7-year-olds, accelerating submission to Q1 2026, while the COMFORT Toddlers study is set to begin in Q2 2025. - The ATM program allows issuance of up to 136,948,870 new shares representing approximately 50% of existing share capital, creating significant dilution risk for current shareholders. - The global peanut allergy treatment market is projected to grow from $0.59 billion in 2024 to $1.21 billion by 2030 at a 12.84% CAGR, driven by rising allergy prevalence and immunotherapy advances.
- DBV Technologies announced a new $150 million at-the-market offering program to sell American Depositary Shares through Citizens JMP Securities as sales agent. - The proceeds will primarily fund activities related to the Biologics License Application, potential approval and launch of VIASKIN Peanut patch for toddlers aged 1-3 years. - The company's VIASKIN patch technology uses epicutaneous immunotherapy to deliver microgram amounts of allergens through intact skin to desensitize the immune system. - DBV Technologies is currently conducting clinical trials of VIASKIN Peanut in both toddlers (1-3 years) and children (4-7 years) with peanut allergies.
- Mabylon AG secured CHF 30 million in funding through equity investment and convertible loan from existing investors, including former Roche management and board members. - The funding will advance lead candidate MY006, a tri-specific antibody neutralizing peanut allergens, to completion of Phase Ia/b trials by 2027 with goals of generating safety and preliminary efficacy data. - MY006 represents a novel approach to peanut allergy treatment by directly blocking allergen-IgE interactions at the molecular level, potentially offering faster protection than current immunotherapy approaches. - The company's pipeline also includes MY010 for birch allergen treatment and MY011 for grass pollen allergies, positioning Mabylon as a leader in human-derived antibody therapeutics.
- DBV Technologies has begun screening the first subject in its COMFORT Toddlers Phase 3 supplemental safety study, evaluating the Viaskin Peanut patch 250 μg in peanut-allergic children ages 1-3 years old. - The double-blind, placebo-controlled study will enroll approximately 480 subjects across 80-90 centers in the U.S., Canada, Australia, UK and Europe over six months with an optional 18-month extension. - Data from COMFORT Toddlers is designed to supplement the completed Phase 3 EPITOPE study and support a Biologics License Application submission to the FDA anticipated in the second half of 2026 under the Accelerated Approval Pathway.
- The injectable drug delivery market is projected to reach $1,139.4 billion by 2029, driven by complex biologics and increased demand for patient self-administration. - Industry leaders from Pfizer, GSK, Sandoz, and other major pharmaceutical companies will gather at the Injectable Drug Delivery Conference in London on June 24-25, 2025. - The conference agenda focuses on critical challenges including subcutaneous delivery of biologics, large-volume injectables, and sustainable device development. - A separate PODD 2025 conference in Boston will feature pharmaceutical innovation leaders discussing strategic partnerships and drug delivery technology evaluation frameworks.
- The peanut allergy treatment market is projected to grow at a 16% CAGR from 2020-2034, driven by current epinephrine usage, anticipated XOLAIR adoption in adults, PALFORZIA expansion to toddlers, and the expected entry of Viaskin Peanut patches. - DBV Technologies' Viaskin Peanut patch leads the pipeline as a promising non-invasive epicutaneous immunotherapy option, with Phase III VITESSE trial results expected in Q4 2025 and potential BLA submission in the first half of 2026. - The market reached USD 400 million in 2024 across seven major markets, with approximately 9.8 million diagnosed prevalent cases, though only 50% of affected individuals in the US received treatment, highlighting significant care gaps. - Stallergenes Greer launched PALFORZIA for toddlers aged 1-3 years in February 2025, while the FDA approved OMLYCLO as the first interchangeable biosimilar for XOLAIR in March 2025.
