VIASKIN Peanut Patch Delivers Breakthrough Results in Phase 3 Study, DBVT Stock Surges

liquidation_surfer · 2025-12-26T03:04:16+00:00

DBV Technologies reports promising outcomes from its Phase 3 VITESSE trial for the VIASKIN Peanut patch, a new treatment for pediatric peanut allergies. With a 31.8% efficacy difference compared to placebo and favorable safety results, the company plans to file for FDA approval by mid-2026 and aims to broaden the treatment's reach.

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2025-12-26 03:04:16

Abstract generation in progress

DBV Technologies achieved a significant milestone with positive Phase 3 VITESSE trial outcomes for its VIASKIN Peanut immunotherapy patch designed for children with peanut allergies. The patch format represents a novel approach to oral immunotherapy, addressing a critical gap in pediatric allergy treatment.

Clinical Trial Success

The global pivotal study enrolled 654 children aged 4-7 years across 86 clinical sites in a randomized, double-blind, placebo-controlled design. Over 12 months, children received either the VIASKIN Peanut patch or placebo on a 2:1 assignment ratio.

Results exceeded expectations: 46.6% of patch recipients demonstrated positive response compared to just 14.8% in the placebo group—a 31.8 percentage point difference that surpassed the prespecified 15% efficacy threshold. Response was defined by meaningful improvement in eliciting dose thresholds during food challenges, indicating genuine desensitization.

Safety remained favorable. The immunotherapy patch triggered predominantly mild-to-moderate local skin reactions, with discontinuation rates staying low. Treatment-related anaphylaxis occurred in only 0.5% of patients, suggesting the patch format may offer safety advantages for young children with severe allergies.

Post-study, 96.2% of families opted into an open-label extension for continued treatment up to three years, highlighting strong real-world acceptability.

Regulatory and Financial Catalysts

DBVT plans to file a Biologics License Application (BLA) with the U.S. FDA in H1 2026, with expectations for priority review status given the Breakthrough Therapy Designation already awarded to VIASKIN Peanut. The trial success triggered acceleration of warrant exercise provisions, potentially adding €168.2 million to the company’s capital.

As of September 30, 2025, DBVT maintained $69.8 million in cash, funding operations through Q3 2026.

Market Response

The stock surged dramatically on the announcement. DBVT closed the announcement day at $17.98 (down 1.69% intraday) but rallied 57.56% overnight to $28.33, marking a new 52-week high. The stock has traded between $2.74 and $21.50 over the trailing 12 months.

Next Steps

The company will present comprehensive VITESSE data at medical conferences and pursue peer-reviewed publication. Parallel trials are underway evaluating the patch in toddlers aged 1-3 years, potentially expanding the addressable population for this immunotherapy treatment.

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