DBV Technologies (DBVT) provides update on Viaskin Peanut

DBV Technologies provides update on Viaskin Peanut; BLA withdrawn following discussions with FDA regarding insufficient data 

• Co announced that after discussions with the FDA, its Biologics License Application for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn. DBV is currently working closely with the agency to resubmit the application for Viaskin Peanut as quickly as possible. This action was based on verbal and written correspondence with the FDA on December 18th, 2018. Following feedback from the agency, DBV Technologies concluded that the current BLA, which was submitted on October 18th, 2018, lacks sufficient detail regarding data on manufacturing procedures and quality controls. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut, and the Company believes that the additional information needed to support this filing is available without further clinical studies.
• DBV anticipates that all ongoing clinical trials with Viaskin Peanut will continue as planned.

** charts before announcement **