DBV Technologies slumps as it pulls Viaskin Peanut BLA

20 December 2018

French biopharma company DBV Technologies (Nasdaq: DBVT) announced after market close on Wednesday that, after discussions with the US Food and Drug Administration, its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn.

DBV concluded that its submission lacked “sufficient detail regarding data on manufacturing procedures and quality controls,” but said it is currently working closely with the agency to resubmit the application for Viaskin Peanut as quickly as possible.

DBV’s shares were down 66% to $4.82 in pre-market New York trading this morning, while peanut allergy competitor Aimmune Therapeutics (Nasdaq: AIMT) was up12% premarket.

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