DBV Technologies Down 16%
October 28 2021 - 4:19PM
Dow Jones News
By Josh Beckerman
DBV Technologies SA shares were recently down 16% to $3.03,
following a 29% decline on Wednesday.
The company said Tuesday that the U.S. Food and Drug
Administration "requested a stepwise approach" to the development
program of its Viaskin Peanut patch for treatment of peanut
allergy.
The agency would like to review data from DBV's protein uptake
release study prior to providing additional comments on protocol
design for the STAMP clinical trial, DBV said. The trial won't
begin until DBV receives complete feedback from the FDA, the
company said.
A European review is progressing, and DBV is preparing its
response to a "Day 180 letter." The company estimates the European
Medicines Agency could issue a decision on potential marketing
authorization in the first quarter of 2022.
On Tuesday, the company also reported a third-quarter loss of 44
cents a share, compared with a loss of 56 cents a share a year
earlier.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
October 28, 2021 16:04 ET (20:04 GMT)
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