Revance Still Sees DAXI Green Light This Year; Shares Rise Premarket
October 13 2021 - 9:13AM
Dow Jones News
By Colin Kellaher
Shares of Revance Therapeutics Inc. rose more than 10% in
premarket trading Wednesday after the biotechnology company said it
still expects U.S. Food and Drug Administration approval of its
injection treatment for frown lines by the end of the year.
Revance shares tumbled 25% on Tuesday after the FDA, responding
to a Freedom of Information Act request, released a document
outlining concerns raised by a pre-approval inspection of the
company's manufacturing plant in late June and early July.
The FDA early last year accepted Revance's application for
DaxibotulinumtoxinA for Injection, or DAXI, with a decision
expected before the end of the year. However, the agency deferred
its decision because it hadn't been able to inspect the California
manufacturing plant due to travel restrictions related to the
Covid-19 pandemic.
Revance late Tuesday said the issuance of the FDA document,
known as a Form 483, following an inspection isn't uncommon and
doesn't constitute a final determination. The Newark, Calif.,
company said it responded to the Form 483 in July, and that its
application remains under FDA review.
Several Wall Street analysts reiterated positive recommendations
for Revance shares, noting that while the Form 483 could raise some
worries about DAXI's approval, the document is heavily redacted,
making the FDA's observations difficult to interpret.
Analysts at Piper Sandler, noting Revance's comment that it
still expects a green light by the end of the year, said they give
the company the benefit of the doubt and reiterated an overweight
stance and $37 a share price target.
Wells Fargo, with a $35 price target on the stock, said
Tuesday's selloff made the Revance risk/reward more favorable and
reiterated an overweight recommendation.
Revance shares, which closed Tuesday at $20.45 after hitting a
52-week low of $19.51 during the session, were recently up 12% to
$22.89 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 13, 2021 08:58 ET (12:58 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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