DBV Technologies Shares Down On FDA Update For Its Peanut Allergy Program

DBV Technologies DBVT has received communication from the FDA concerning the STAMP protocol submission for its modified Viaskin Peanut (mVP) development program.
The agency would like to review DBV's protein uptake release study data before providing additional comments on the STAMP protocol design.
In May, DBV submitted the protocol for the 6-month adhesion and safety study of the modified patch (STAMP) study.
The Company will not initiate the STAMP trial until it receives complete feedback from the FDA.
The EMA review of the Viaskin Peanut Marketing Authorization Application is progressing.
DBV estimates the EMA could issue its decision on potential marketing authorization for Viaskin Peanut in 1Q 2022.
The Company posted a narrower Q3 EPS loss of $(0.44) versus $(0.56) a year ago. Cash and cash equivalents stood at $98.2 million.
Related content: Benzinga's Full FDA Calendar.
Price Action: DBVT shares are down 23.40% at $3.87 during the premarket session on the last check Wednesday.