CTI BioPharma Shares Slide as FDA Extends Pacritinib Review
By Colin Kellaher
Shares of CTI BioPharma Corp. fell nearly 20% on Wednesday after
the U.S. Food and Drug Administration extended its review of the
company's application seeking approval of pacritinib, its lead
product candidate, in certain patients with the bone-marrow cancer
The Seattle biopharmaceutical company said the delay comes after
it recently submitted additional clinical data in the course of
product labeling discussions with the FDA.
CTI said the agency, which had previously granted priority
review to the application with a target action date of Nov. 30,
determined that the submission constitutes a major amendment to the
application and extended the target action date to Feb. 28, 2022,
to allow for a full review of the submission.
Analysts at Stifel said they still model an 85% probability of
approval for pacritinib, adding that they believe the delay has
more to do with the FDA needing more review time than it does with
any potential shortcoming in the pacritinib data.
CTI, which is seeking approval of pacritinib for the treatment
of adults with intermediate or high-risk primary or secondary
myelofibrosis, noted that it isn't aware of any major deficiencies
in the application.
Stifel, which has a "buy" rating and a $5.50 target price on CTI
shares, said it remains bullish and recommends investors take
advantage of the pullback in the stock.
CTI shares were recently down 18%, to $1.845, just above a
52-week low of $1.835 hit earlier in the session.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
December 01, 2021 11:10 ET (16:10 GMT)
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