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DBV Technologies S.A. (symbol: DBVT) is a clinical-stage specialty biopharmaceutical company revolutionizing the treatment of food allergies, a significant and growing public health issue. Founded in 2002, the company has developed a groundbreaking technology platform known as Viaskin®.
Viaskin® employs epicutaneous immunotherapy (EPIT), a proprietary method that administers allergens through an epicutaneous patch applied to intact skin. This innovative approach targets Langerhans cells, specialized immune cells in the skin, which capture the allergen and migrate to the lymph nodes. This mechanism allows for activation of the immune system without introducing the allergen into the bloodstream, thus minimizing systemic exposure and the risk of severe allergic reactions.
DBV Technologies' flagship product, Viaskin Peanut, is designed for peanut-allergic patients. The patch aims to improve patient tolerability to peanuts and significantly reduce the risk of life-threatening allergic reactions upon accidental exposure. Clinical trials have demonstrated the product's efficacy and safety, making it a promising solution for millions of individuals affected by peanut allergies.
In addition to peanut allergies, DBV Technologies is expanding its portfolio to address other food allergies like milk. The company's robust pipeline and innovative approach position it at the forefront of allergy treatment research.
DBV Technologies has secured multiple worldwide patents for its Viaskin® technology, underlining its pioneering role in the field of immunotherapy. The company continually collaborates with leading research institutions and partners to advance its clinical programs and bring new therapies to market.
Recent achievements include significant milestones in clinical trials, regulatory submissions, and strategic partnerships, reflecting DBV Technologies' commitment to developing safe and effective treatments for food allergies. The company's dedication to addressing unmet medical needs ensures it remains a crucial player in the biopharmaceutical landscape.
DBV Technologies has outlined its regulatory path for the Viaskin Peanut 250 μg patch, targeting toddlers aged 1-3 years with peanut allergies, after receiving feedback from the FDA. The FDA confirmed that the Phase 3 EPITOPE study achieved its primary endpoint without requiring an additional efficacy study. However, a new safety study is mandated to augment existing data, aiming for a database of around 600 patients. As of March 31, 2023, the company reported cash equivalents of $192.3 million, a decrease from $209.2 million at year-end 2022. DBV is committed to developing treatment options for young children with peanut allergies, and it plans to submit a proposed protocol for the safety study to the FDA by the end of Q2 2023.
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