CTI BioPharma Tanks Post Type B Talks on Pacritinib With FDA
Shares of CTI BioPharma Corp. CTIC plunged 43.4% after the company announced the outcome of a Type B meeting with the FDA, discussing a regulatory pathway for its lead pipeline candidate pacritinib. Per the FDA’s request, the company will have to conduct a phase III study on patients with myelofibrosis.
The news comes as a major setback for investors as it implies additional cost for the company along with a delay in potential approval.
In fact, so far this year, CTI Biopharma stock has lost 15.7% against the industry’s increase of 3.3%.
Pacritinib, an investigational oral kinase inhibitor, is being evaluated in a phase II PAC203 trial for the treatment of myelofibrosis. PAC203 program is expected to complete enrollment by the end of 2018 with full top-line data expected in the second quarter of 2019.
The dosing for the phase III study will be determined based on the results of the PAC203 study. The new phase III study is expected to open in 2019.
The company anticipates the new study to address the unmet medical needs of patients suffering myelofibrosis, primarily for those with severe thrombocytopenia. The company plans to request an additional meeting with the FDA, after the second interim analysis, to discuss interim data from PAC203 trial along with the design of the new phase III study.
In June, the Independent Data Monitoring Committee (IDMC) reviewed the PAC203 study and a second interim review is scheduled during the third quarter of 2018. The study is evaluating the safety and efficacy of three dosing schedules (100 mg once daily, 100 mg twice daily and 200 mg twice daily) over 24 weeks (n=150) on patients with myelofibrosis, previously treated with Incyte Corporation’s INCY Jakafi (ruxolitinib).
We remind investors that in February 2016, the FDA had placed the company’s Investigational New Drug application for pacritinib on a full clinical hold. However, the FDA removed the same in January 2017.
CTI BioPharma currently has a Zacks Rank #4 (Sell).
Two better-ranked stocks in the same sector are AcelRx Pharmaceuticals, Inc. ACRX and BioLineRx Ltd. BLRX, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AcelRx’ loss per share estimates have been narrowed by 13.2% for 2018 and 23.5% for 2019 over the past 60 days. The stock has soared 43.3% so far this year.
BioLineRx’s loss per share estimates have been narrowed by 16.1% for 2018 and 15.1% for 2019 over the past 60 days.
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