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 myelofibrosis.
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