CTI BioPharma Corp. (NASDAQ:CTIC) and Baxalta Inc(NYSE:BXLT) announced the completion of the rolling submission of the New Drug Application (NDA) to theU.S. Food and Drug Administration (FDA) for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. CTI BioPharma and Baxalta are requesting U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000/μL) – a specific patient population for which there is an existing unmet medical need. The Companies are seeking accelerated approval and have requested a Priority Review of the application.
Pacritinib is an investigational treatment being developed for patients with myelofibrosis regardless of their platelet counts. If approved, pacritinib would be the first JAK2 inhibitor indicated for the treatment of patients with myelofibrosis and baseline platelet counts of less <50,000/μL.
“We are pleased to have completed the rolling submission and look forward to working with theFDA during the review process with the goal of bringing this important treatment to people living with myelofibrosis, including those with low platelet counts,” said James Bianco, M.D., president and chief executive officer of CTI BioPharma.
Myelofibrosis is a rare, but serious and life-threatening chronic leukemia that disrupts the normal production of blood cells and results in scarring of the bone marrow, limiting the ability to produce new blood cells and prompting the spleen and other organs to take over this function. The disease often leads to an enlarged spleen and lower than normal counts of blood cells – including red blood cells and platelets, which are essential for blood clotting.
“Pacritinib has the potential to change the treatment paradigm for people with intermediate and high-risk myelofibrosis, particularly those patients with cytopenias,” said David Meek, executive vice president, president of Oncology at Baxalta. “Together with CTI BioPharma, we are continuing to develop this potential new treatment for more people in need around the world.” (Original Source)
Shares of CTI BioPharma Corp. closed yesterday at $1.23. CTIC has a 1-year high of $2.94 and a 1-year low of $0.80. The stock’s 50-day moving average is $1.17 and its 200-day moving average is $1.56.
On the ratings front, CTI BioPharma has been the subject of a number of recent research reports. In a report issued on December 10, Piper Jaffray analyst Charles Duncan reiterated a Buy rating on CTIC, with a price target of $8, which implies an upside of 550.4% from current levels. Separately, on November 9, WallachBeth Capital LLC’s Bob Ai downgraded the stock to Hold and has a price target of $1.60.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Charles Duncan and Bob Ai have a total average return of 5.0% and -12.2% respectively. Duncan has a success rate of 44.7% and is ranked #753 out of 3648 analysts, while Ai has a success rate of 20.0% and is ranked #3208.