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March 3, 2014
05:25 EDTCTICCell Therapeutics opens enrollment for PERSIST-2 Phase 3 trial of pacritinib
Cell Therapeutics announced the initiation of a Phase 3 clinical trial, known as PERSIST-2, which will evaluate pacritinib, a novel, investigational JAK2/FLT3 inhibitor, in patients with myelofibrosis whose platelet counts are less than or equal to 100,000 per microliter. The trial is expected to enroll up to 300 patients in North America, Europe, Australia and New Zealand within 12 to 14 months. In October 2013, CTI reached agreement with the FDA on a Special Protocol Assessment for the PERSIST-2 trial, which is a written agreement between CTI and the FDA regarding the planned design, endpoints and statistical analysis approach of the trial to be used in support of a potential New Drug Application, or NDA, submission. PERSIST-2 is the second of two planned Phase 3 trials in the pacritinib development program for myelofibrosis.
News For CTIC From The Last 14 Days
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January 13, 2015
09:07 EDTCTICOn The Fly: Pre-market Movers
HIGHER: Apple (AAPL), up 1.4% after Credit Suisse upgraded Apple to Outperform and raised its iPhone volume estimates again... Best Buy (BBY), up 2.8% after being upgraded to Buy from Neutral at Goldman... SunPower (SPWR), up 2.6% after being upgraded to Outperform at Credit Suisse... Alcoa (AA), up 2% after Q4 results beat expectations. RISING AFTER GUIDANCE: Pharmacyclics (PCYC), up 17.5%... CTI BioPharma (CTIC), up 8.3%... Emulex (ELX), up 15.5%... ARIAD (ARIA), up 2.6%. LOWER: ChannelAdvisor (ECOM), down 42% following preliminary fourth quarter revenue guidance and after receiving multiple analyst downgrades... Antares Pharma (ATRS), down 7.7% after the FDA recommended that the company create a larger safety database for its clinical development program for QuickShot Testosterone.
07:50 EDTCTICCTI BioPharma sees FY15 revenue $55M-$72M, consensus $36.89M
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