DBV Technologies SA
NASDAQ:DBVT
DBV Technologies SA
DBV Technologies SA is a clinical-stage biopharmaceutical company, which engages in the research and development of epicutaneous immunotherapy products. The company is headquartered in Montrouge, Ile-De-France. The company went IPO on 2012-03-29. The firm's therapeutic approach is based on epicutaneous immunotherapy, or EPIT, its proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. The company dedicates its technology to treat patients, including infants and children, suffering from severe food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. The firm's product portfolio for allergy treatments consists of Viaskin Peanut, Viaskin Milk and Viaskin Egg. The firm operates one subsidiary DBV Technologies Inc. in the United States.
DBV Technologies SA is a clinical-stage biopharmaceutical company, which engages in the research and development of epicutaneous immunotherapy products. The company is headquartered in Montrouge, Ile-De-France. The company went IPO on 2012-03-29. The firm's therapeutic approach is based on epicutaneous immunotherapy, or EPIT, its proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. The company dedicates its technology to treat patients, including infants and children, suffering from severe food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. The firm's product portfolio for allergy treatments consists of Viaskin Peanut, Viaskin Milk and Viaskin Egg. The firm operates one subsidiary DBV Technologies Inc. in the United States.
VITESSE Trial Progress: Enrollment in the key VITESSE Phase III trial for Viaskin Peanut in children ages 4–7 remains on track, with final screening expected by end of Q3 2024.
Regulatory Dialogue: Ongoing discussions with the FDA continue regarding the COMFORT Toddlers safety study protocol and proposed product labeling, with DBV awaiting agency feedback.
Cash Runway Extended: Cost-saving measures have extended the company’s cash runway into Q1 2025, beyond the previous year-end 2024 guidance.
Financial Performance: Operating expenses increased due to clinical activity and nonrecurring costs, leading to a net loss of $60.5 million for the first half.
Upcoming Milestones: Key expected milestones include VITESSE enrollment completion, FDA feedback on toddler studies and labeling, and year 3 results from the EPITOPE trial.
