DBV Gets Green Light from FDA

DBV Technologies (NASDAQ:DBVT) shares slumped Wednesday, on news that company has received communication from the Food and Drug Administration 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 six-month adhesion and safety study of the modified patch (STAMP) study.

DBVT 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.

The 32% decrease in net cash used in operating activities between the first nine months of 2020 and 2021 reflects the Company’s continued implementation of cost containment measures and the decrease in personnel expenses related to the workforce reduction as part of the Company’s global restructuring plan.

"DBV is working hard to find an efficient and timely path forward. On behalf of patients and providers urgently awaiting a therapeutic advancement in treating peanut allergy, DBV will continue to pursue our goal of bringing Viaskin Peanut to the food allergy community," said CEO Daniel Tasse,.

DBVT shares tumbled $1.22, or 24.2% at $3.83, soon after Wednesday’s open.