DBV Technologies S.A. (NASDAQ: DBVT) shares jumped 27.36% to $4.19 on the US stock charts during Wednesday’s after-hours trade. The cause for that spike in DBVT stock price was the disclosure of significant regulatory advancements with the U.S. Food and Drug Administration (FDA) concerning their Viaskin Peanut patch product.
Faster Approval Process
Successful written and verbal interactions with the FDA resulted in a clearly defined regulatory process for the Viaskin Peanut patch, which is intended for children ages one to three, according to Defined DBV Technologies (DBVT). The FDA agreed with DBVT on the essential components of a post-marketing confirmatory study design and issued official guidelines in favor of the product’s Accelerated Approval.
This progress significantly reduces regulatory uncertainty and allows DBV Technologies to focus on completing studies to support two Biologics License Applications (BLAs) for distinct age groups and a Marketing Authorization Application (MAA) in Europe.
Efficacy Data Validated for Accelerated Approval
The FDA confirmed that efficacy data from DBV Technologies’ Phase 3 EPITOPE study could serve as an intermediate clinical endpoint, satisfying the criteria for Accelerated Approval.
The regulatory body acknowledged that the data is “reasonably likely to predict clinical benefit,” meeting one of the three qualifying criteria for Accelerated Approval, which also includes addressing a serious condition and providing meaningful advantages over available therapies. This confirmation marks a pivotal step toward the commercialization of the Viaskin Peanut patch.
Preparations for Commercialization
DBV Technologies has implemented changes to improve the patch’s usability and production efficiency in anticipation of commercialization. These modifications, such as simplifying application for caregivers and enhancing product identification, do not alter the patch’s interaction with patients. Additionally, adjustments to the manufacturing process and location have been made to scale up production volume, ensuring readiness for broader market distribution.
Strategic Focus on Global Approvals
With a clearer regulatory pathway, DBV Technologies is poised to advance its Viaskin Peanut programs for both toddlers and older children, addressing unmet needs in allergen immunotherapy. This milestone underscores DBVT’s commitment to innovation and its readiness to bring transformative solutions to market.
