CTI BioPharma (CTIC) Receives Fast Track FDA Status

CTI BioPharma Corp (CTIC) received FDA Fast Track Designation for Pacritinib Wednesday night and the stock is on fire this morning. Shares of the biopharmaceuticals company are higher by almost 4% to $2.54 in early premarket trading.

The Seattle, Washington – based company announced that Pacritinib, an oral tyrosine kinase inhibitor drug-candidate with dual activity against JAK2 and FLT, “has been granted Fast Track designation by the U.S. Food & Drug Administration for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy.”

The drug candidate is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis.

The fast-track designation means that FDA officials will have increased communication with CTI’s execs throughout the development process and facilitate a speedy review when a “New Drug Application” is submitted.

“We are very pleased that the pacritinib development program in myelofibrosis has been granted Fast Track designation, and we look forward to continuing to work closely with the FDA on this important drug candidate,” James A. Bianco, M.D., President and CEO of CTI BioPharma said in a statement.

CTI’s stock was raised to ‘Buy’ from ‘Hold’ and had its $4.50 price target reiterated at institutional broker WallachBeth Capital on Tuesday. The firm, whose target price suggests a potential upside of 83.67% from the company’s previous close, believes ticker’s current price-per-share represents an opportunity for sophisticated investors to accumulate shares.

Over the last 52 weeks, CTIC has been trading between $1.01 and $4.25. More recently in the last 4 weeks, the stock has been trading between $3.00 and $2.43. The $367 million market cap company reported $50.06 million in cash vs. $13.39 million in debt in its most recent quarter.

CTI’s 50-day moving average is $2.54 and its 200-day moving average is $2.82.

The chart below shows where the equity has traded over the last 52 weeks, with the 50-day and 200-day MAs included.

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