Pomerantz LLP is investigating claims on behalf of investors of DBV Technologies S.A. (DBV Technologies" or the "Company"). The investigation concerns whether DBV Technologies and certain of its officers and/or directors have violated the federal securities laws.
On October 22, 2018, the Company announced the submission of a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. When the Company announced the submission of the BLA Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies, stated that "This submission represents a significant step forward for those families living with peanut allergy. We are thankful for the patients, investigators and DBV employees' efforts in making this milestone possible…We have been developing Viaskin Peanut for over 10 years, with over 1,000 patients studied in our clinical trials, and we are excited about the possibility of helping patients suffering from peanut allergy."
On December 19, 2018, DBV Technologies revealed that its BLA for Viaskin Peanut had been voluntarily withdrawn following discussions with the FDA. The Company stated, "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." On this news shares of DBV Technologies fell $8.39or nearly 60% to close at $5.76 on December 20, 2018.