DBV Jumps 41% To $9.96 After Update On Viaskin Peanut Filing

Shares of DBV Technologies (DBVT) jumped after the company said that its planned resubmission of the Biologics License Application to the FDA for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019. "We appreciate the detailed feedback the FDA provided in December 2018, which has allowed us to make meaningful headway in addressing the information requests needed for a BLA resubmission," said Daniel Tasse, CEO of DBV Technologies. "We are working diligently on our Viaskin Peanut BLA, bringing us one step closer to potentially providing an FDA-approved treatment for peanut-allergic children and their families."

In December 2018, DBV voluntarily withdrew its BLA for Viaskin Peanut following correspondence with the FDA regarding additional data needs on manufacturing procedures and quality controls. "Based on the progress in addressing the FDA's guidance, the Company anticipates compiling the required information for the resubmission of its Viaskin Peanut BLA in the third quarter of 2019," DBV said in a statement.

The stock in after-hours trading jumped 41%, or $2.91, to $9.96. In an interview with Bloomberg, Tasse added, "I assume people will be pleased that we will file in 3Q which is, by our standard, a reasonable amount of time...We are in a position where we will have cash into 4Q, so on the other side refiling the submission, and we will look at the right opportunity to raise capital as circumstances play out." Aimmune Therapeutics (AIMT), which is also developing a treatment for peanut allergy, is trading down in after-hours 31c to $23.50.

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