Crispr Therapeutics Shares Rally Premarket After Favorable FDA Panel Meeting
01 Novembre 2023 - 11:29AM
Dow Jones News
By Colin Kellaher
Shares of Crispr Therapeutics jumped nearly 20% in premarket
trading Wednesday following a U.S. Food and Drug Administration
advisory committee meeting on the proposed gene-editing drug
exa-cel from Crispr and partner Vertex Pharmaceuticals that
analysts believe paves the way for FDA approval.
Crispr and Vertex are seeking FDA approval of exa-cel in
sickle-cell disease, an inherited blood disorder, and a green light
would make exa-cel the first approved drug using the gene-editing
technology known as Crispr.
The FDA often turns to advisory committees to obtain advice from
experts who work outside of the government when a scientific,
technical or policy question arises, such as whether an unapproved
product is safe and effective.
The advisory committee meeting on Tuesday, which unusually
didn't include a vote on exa-cel, focused on the drug's potential
off-target effects.
In a research note, analysts at Citigroup said the overwhelming
consensus from the discussion was that benefit/risk for exa-cel is
exceedingly favorable, and that they expect an FDA approval with
off-target monitoring language.
Analysts at Truist and Mizuho also said they expect an approval
from the FDA, which has set a Dec. 8 target action date.
Trading in Crispr shares was halted Tuesday while the advisory
committee held its all-day meeting. The shares, which closed Monday
at $38.93, were recently up 19% to $46.30 in premarket trading.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 01, 2023 06:14 ET (10:14 GMT)
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