Shares of DBV Technologies S.A. (NASDAQ: DBVT) shot up on Thursday after the company announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut for the treatment of peanut-allergic children ages 4 to 11 years.
The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including, two Phase 1 studies, four Phase 2 studies and two Phase 3 studies, as well as two double-blind placebo-controlled Phase 3 trials.
Viaskin Peanut is the company’s lead product candidate based on epicutaneous immunotherapy. Viaskin is the company’s proprietary, investigational platform that is designed to leverage the skin to activate the immune system and induce desensitization to allergens.
This submission addresses the additional data needed on manufacturing procedures and quality controls that were communicated by the FDA in December 2018, when the firm voluntarily withdrew its prior BLA submission for Viaskin Peanut.
Previously, Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively.
Daniel Tassé, CEO of DBV Tech, commented:
This is an important milestone for DBV, as we are one step closer towards potentially bringing Viaskin Peanut to patients. I want to thank the team for their dedication in working to address the FDA’s findings over the past few months. Everyone at DBV is highly committed to potentially addressing the significant unmet medical need facing peanut-allergic patients. We would also like to thank our investigators, clinical trial sites, as well as the children living with peanut allergy and their families for all of their help in the development of Viaskin Peanut. We look forward to working with the FDA throughout its review process.
Shares of DBV Tech traded up about 14% Thursday morning, at $10.40 in a 52-week range of $3.60 to $25.77. The consensus price target is $20.17.