DBV Technologies (NASDAQ:DBVT) Chief Executive Officer Daniel Tassé said the company is preparing to file a biologics license application for Viaskin Peanut, its lead product candidate for pediatric peanut allergy, within the next several weeks.
Speaking at an H.C. Wainwright event with biotechnology analyst Andrew Fein, Tassé described DBV as an immunology company focused on food allergy in pediatric populations. Its Viaskin platform is designed to desensitize patients through the skin using a patch-based approach. Tassé said the company’s initial regulatory focus is children ages 4 to 7, with a separate filing pathway for children ages 1 to 3 expected by the end of 2026.
CEO Highlights Peanut Allergy Market Need
Tassé said peanut allergy remains a major source of concern for parents because peanuts are widely present in food products and allergic reactions can be unpredictable. He said parents often view peanut allergy as a “higher order need” because a prior reaction does not necessarily indicate how severe a future reaction may be.
He contrasted Viaskin Peanut with existing and emerging treatment options. Tassé said oral immunotherapy is available largely through “homebrew” approaches, while an approved product is expected to come off the market later this summer. He also discussed Xolair, a monoclonal antibody approved for older children with multiple allergies, but said DBV is seeing little use in the 1-to-7-year-old population it is targeting.
According to Tassé, parents may be drawn to the convenience of Viaskin Peanut because the patch takes about 10 seconds to apply each night. He said the product could give parents the sense that they are doing what they can to protect their child.
Regulatory Pathway Now ‘Very Clear,’ Tassé Says
Tassé acknowledged that DBV’s regulatory process has taken longer than expected. He attributed part of the delay to the novelty of the company’s drug-device combination and the need to address U.S. Food and Drug Administration questions about the product’s characterization and manufacturing.
He said the company is reviewed by the FDA’s vaccine division and that earlier questions from the agency were complicated by the pandemic. However, Tassé said DBV has since engaged in detailed discussions with FDA reviewers, including scientists, biostatisticians and chemistry, manufacturing and controls experts.
“All of that is behind us now,” Tassé said. “We have a clear regulatory pathway in children four to seven.”
He said the company has breakthrough designation and plans to request priority review, which would give the FDA a six-month review timeline rather than 10 months if granted. Tassé said the remaining work involves assembling the BLA in a way that addresses the agency’s clinical and CMC requirements.
Patch Adhesion and Clinical Response
Fein asked which part of the data Tassé viewed as most important in addressing prior FDA concerns. Tassé pointed to the agency’s earlier questions about patch adhesion and what happens when the patch falls off before a full day of wear.
Tassé said DBV’s position is that the key issue is whether wear time is sufficient to produce a clinical response. He said the company and FDA ultimately focused on the clinical outcome over time rather than on any single daily measurement of patch wear.
“It’s really a question of clinical response, because if it’s sufficient, by definition, the wear time was sufficient,” Tassé said.
Pipeline Includes Milk, Celiac and Multi-Allergen Concepts
Tassé said about half of children with peanut allergy in both real-world settings and DBV’s clinical studies have another food allergy. He said the presence of other allergies, asthma, atopic dermatitis or other atopic conditions did not affect Viaskin Peanut’s clinical response or safety profile in the company’s studies.
Beyond peanut allergy, Tassé said DBV is “phase II-B ready” for cow’s milk allergy and has discussed that program with the FDA. He said the company will “probably” enter the clinic early next year. He also described a pre-IND celiac program as promising.
The company is also exploring the possibility of a multi-allergen patch, such as one addressing multiple tree nuts. Tassé said the FDA showed willingness at a February food allergy expert panel to engage with industry on a regulatory pathway for multi-allergen desensitization, though he emphasized that “a lot of work” remains.
Commercial Strategy to Focus First on Allergists
On commercialization, Tassé said current American Academy of Pediatrics guidelines recommend avoiding the food, prescribing an epinephrine device and referring patients to an allergist. He said about 60% of children ages 1 to 7 with peanut allergy are already seeing an allergist, whether for peanut allergy, asthma or another condition.
While pediatricians are often the first point of contact, Tassé said DBV believes directing patients to allergists is preferable in the short term. He cited allergists’ experience with prior authorizations, access to more complex products and documentation such as skin prick testing and peanut-specific IgE testing.
Tassé said the company’s challenge is not primarily displacing an established competitor, but persuading parents who have learned to manage peanut allergy through label reading, vigilance and carrying epinephrine that adding Viaskin Peanut could reduce anxiety and improve management.
He said DBV is conducting market research to identify families most willing to add Viaskin to a treatment regimen and plans to hold an investor day on commercialization as it gets closer to launch.
“We still have work to do, but we’re entirely focused on it,” Tassé said.
About DBV Technologies (NASDAQ:DBVT)
DBV Technologies SA is a clinical-stage biopharmaceutical company engaged in developing immunotherapies for allergic diseases. The company specializes in epicutaneous immunotherapy, leveraging its proprietary Viaskin platform to deliver biologically active compounds across intact skin without needles or injections. Through this approach, DBV aims to modulate patients’ immune response to specific allergens, offering a potentially safer and more convenient alternative to traditional therapies.
The company’s lead product candidate, Viaskin Peanut, is designed for the treatment of peanut allergy in children and adolescents.
