DBV Technologies S.A. (NASDAQ: DBVT) shares dipped early Monday after the firm announced an update from the U.S. Food and Drug Administration (FDA). Although it was a positive update for DBV Tech, this appears to be a case of “sell the news.”
Specifically, the FDA accepted for review the Biologics License Application (BLA) for its investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
Viaskin Peanut is the DBV Tech’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts.
The target action date provided by the FDA is August 5, 2020. The FDA has communicated that it is currently planning to hold an advisory committee meeting to discuss the Viaskin Peanut application. The product previously received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively.
The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including two Phase 1 clinical trials, four Phase 2 clinical trials and two Phase 3 clinical trials.
CEO Daniel Tassé commented:
The acceptance of the Viaskin Peanut BLA is a meaningful step forward for peanut-allergic patients and their families. We commend the tireless efforts of the DBV team, the investigators and the more than 1,000 patients living with peanut allergies who participated in our clinical trials and made this milestone possible. We know children and their families are seeking a safe and effective treatment that may fit into their daily lives. We look forward to continuing to work with the FDA to potentially bring Viaskin Peanut to patients in the second half of 2020.
Shares of DBV Tech traded down almost 6% early Monday at $8.38, in a 52-week range of $3.60 to $20.10. The consensus price target is $15.71.
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