France · Delayed Price · Currency is EUR DBV Technologies Earnings Call Transcripts
Fiscal Year 2026
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VIASKIN showed 47% efficacy on active treatment vs 14% on placebo at 1 year, and the 4–7 BLA is under FDA consideration. Commercial preparations target a 600,000-child peanut-allergy market, with launch expected within weeks after PDUFA.
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The 4–7-year-old VIASKIN Peanut BLA was submitted, with FDA review and Fareva remediation central to execution. Q3 ended with $165.7M in cash and runway forecast into Q3 2027; a toddler BLA is expected in 2027.
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VIASKIN Peanut BLA filings are planned for ages 4–7 by end-Q3 2026 and ages 1–3 by year-end 2026. Management targets an internal launch, with cash runway into Q3 2027 and THRIVE focused on potential post-treatment disease modification.
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Epicutaneous immunotherapy for peanut allergy in children shows strong safety, convenience, and long-term efficacy, with 68.2% tolerating full food challenges after three years. Regulatory progress is advanced, and the THRIVE study aims to demonstrate lifelong desensitization in infants.
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Progress toward commercialization continues with BLA submission for the VIASKIN Peanut Patch targeted for Q3 2026 and priority review requested. Clinical programs advance with completed toddler safety study recruitment and new infant studies, while funding is secured into Q3 2027.
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Detailed pre-filing discussions with the FDA have led to actionable feedback on the BLA for the VIASKIN Peanut patch in children aged four to seven, focusing on data organization and review efficiency. Submission remains on track for Q3, with lessons from this process expected to benefit future filings, including for younger children.
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A novel skin-based immunotherapy for pediatric peanut allergy is nearing BLA filing, with a clear regulatory path and plans for pipeline expansion into other food allergies. Market entry will focus on allergists and parental engagement, with future growth driven by platform efficiencies and new indications.
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Epicutaneous immunotherapy for peanut allergy in young children is advancing, with two BLAs planned for 2026 and strong clinical efficacy and safety data. Launch preparations are underway, supported by a robust cash position and plans to expand the pipeline to cow’s milk protein.
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Two BLAs for Viaskin Peanut targeting children with peanut allergy are planned for 2026, supported by strong efficacy and safety data. Commercial launch is expected in 2027, with a focus on allergists and a differentiated, patch-based therapy. The company is well-funded and preparing for future pipeline expansion.
Fiscal Year 2025
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The phase III VITESSE trial in children aged 4–7 met its primary endpoint, showing a 46.6% responder rate and a strong safety profile, paving the way for BLA submission in 2026. The results are consistent across ages one to seven, with high compliance and significant commercial potential.
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A novel patch-based immunotherapy for peanut allergy in children is advancing, with two independent programs targeting ages one to seven. The pivotal VITESSE trial is highly powered, with data expected soon, and strong FDA engagement supports regulatory progress. Commercial and manufacturing plans are in place for launch, with robust financials through 2026.
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The COMFORT Toddlers safety study has begun, supporting an accelerated BLA submission for VIASKIN Peanut in toddlers, with consistent inclusion criteria and strong investigator engagement. Favorable safety and efficacy data from EPITOPE and its extension underpin the program, while parallel progress continues in older children.
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The company is advancing a skin patch for pediatric peanut allergy, with pivotal trial results for 4-7 year olds expected in Q4 2025 and BLA filings for both 1-3 and 4-7 age groups planned for 2026. Recent financing secures operations through key milestones.
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FDA agreement allows earlier BLA submission for Viaskin Peanut in children 4–7, eliminating a supplemental safety study and accelerating potential launch by a year. Financing of up to $306.9 million secures funding through BLA and commercialization, while clinical trial design and market positioning remain strong.
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Three-year data from the open-label extension of the EPITOPE Phase III trial in toddlers show sustained efficacy and improved tolerability for Viaskin Peanut, with nearly 70% tolerating 12–14 peanut kernels. Early patch wear time predicts response, supporting a data-driven labeling strategy.
Fiscal Year 2024
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FDA has confirmed an accelerated approval pathway for Viaskin Peanut in toddlers, with clear alignment on study design, endpoints, and post-marketing requirements. Both toddler and child programs are on track for BLA submissions in the second half of 2026, with pivotal studies launching in 2025.
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FDA granted an accelerated approval pathway for the VIASKIN Peanut patch in toddlers, requiring a six-month safety study and a post-marketing confirmatory trial. The VITESSE study in older children is fully enrolled, and both US and EU regulators have provided clear paths forward for approval.
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A novel skin-based immunotherapy for pediatric peanut allergy is advancing through two parallel FDA tracks, targeting significant unmet needs in young children. Key milestones include imminent FDA feedback, new clinical data releases, and anticipated commercialization by 2026–2027.
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VIASKIN Peanut's pivotal trials in children and toddlers are progressing, with regulatory engagement ongoing and a proposed labeling approach under FDA review. Cost-saving measures have extended the cash runway into Q1 2025, despite a net loss of $60.5 million in H1 2024.
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The company is advancing two parallel BLAs for its viaskin Peanut patch in children, with strong efficacy and safety data supporting regulatory submissions expected in late 2025. Commercialization will be in-house in the U.S., with partnerships considered for Europe, and additional financing planned around key regulatory milestones.