DBV Technologies pulls peanut allergy treatment from FDA review

DBV Technologies is withdrawing its marketing application for a peanut allergy therapy following discussions with the Food and Drug Administration, the company said Wednesday.

Based on feedback from regulators, DBV concluded that its submission lacked “sufficient detail regarding data on manufacturing procedures and quality controls.” The company believes it can re-file with the FDA without having to conduct any additional clinical trials, although when that will happen was not made clear.

DBV shares were halted at $14.15 ahead of the announcement.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

Already have an account? Log in

Individual plans

Group plans

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$20

for 3 months, then $399/year

$20 for 3 months Get Started

Then $399/year

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

To read the rest of this story subscribe to STAT+.

Subscribe

Log In