French biopharmaceutical firm DBV Technologies SA’s (DBVT) stock is in a free-fall today. Shares are down nearly 70% after the company voluntarily withdrew its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years old. The company is working closely with the US Food and Drug Administration (FDA) to resubmit an application as quickly as possible.
The company had consulted with the FDA before withdrawing the application, and came to the conclusion that the BLA lacked sufficient detail regarding manufacturing procedures and quality control data. On a positive note, the FDA did not say that it was concerned with the clinical module for the Viaskin Peanut. This implies that the company needs to provide additional information, not upend its clinical trials.
CEO of DBV Daniel Tasse said, “Although the agency did not reference any medical or clinical questions with the submission of Viaskin Peanut, the FDA did communicate that the level of detail with regards to data on manufacturing and quality controls was insufficient in the BLA.” He further said the company remains confident in the “clinical profile of Viaskin Peanut and its potential to offer treatment to peanut-allergic children” and that the company plans to address these concerns as soon as possible.
DBV has a comprehensive clinical research program in place for Viaskin Peanut. Two Phase III long-term studies in children ages four to 11 are ongoing, as well as a Phase III trial in patients one to three years of age. DBV’s Viaskin Peanut has obtained Fast Track and Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of peanut allergy in children.
Even amid the fall, Wall Street is optimistic about the DBV’s stock. Over the past 12 months, TipRanks analysis of seven analysts show a consensus Buy rating, with six analysts recommending Buy and one recommending hold. The current average price target is $35, representing a 676% upside to the plummeting stock. (See DBVT’s price targets and analyst ratings on TipRanks)