FDA fast tracks CTI BioPharma's pacritinib for myelofibrosis

US biotech firm CTI BioPharma (Nasdaq: CTIC, formerly called Cell Therapeutics) says that its pacritinib has been granted Fast Track designation by the US Food and Drug Administration.

The FDA designation is 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. Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. The drug candidate is currently being evaluated in two Phase III clinical trials, known as the PERSIST program, for patients with myelofibrosis.

CTI BioPharma’s stock price gained almost 3% yesterday to $2.52, but fell back to $2.22 in premarket trading this morning. The stock is up 31.9% year-to-date. Six analysts rate BioPharma a Buy, while one rates it a Sell. The average 12-month target price on the stock is $4.75, about 88.5% higher than stock’s current price.