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News Breaks
August 12, 2014
16:14 EDTCYCCCyclacel Pharmaceuticals reports Q2 EPS (22c), consensus (30c)
Reports cash and cash equivalents totaled $33.5M as of June 30. The company said, "We are pleased to report that we have enrolled over 70% of the required number of patients in our Phase 3 SEAMLESS trial in front-line AML. At present we have approximately 90 study centers open for enrollment in the US and Europe with additional sites to be added. We expect to complete SEAMLESS enrollment around the end of 2014 with data readout in the second half of 2015. Having surpassed enrollment of 300 patients, we expect the study's Data Safety Monitoring Board to perform the fourth periodic safety review once 60 days of follow-up have been observed."
News For CYCC From The Last 14 Days
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May 12, 2015
16:12 EDTCYCCCyclacel Pharmaceuticals reports Q1 EPS (19c), one estimate (25c)
Reports Q1 revenue $512,000 vs. $396,000 last year. "Approximately 20% of the prespecified events remain to be observed before we unblind SEAMLESS, our pivotal, Phase 3 study of sapacitabine in patients aged 70 years or older with acute myeloid leukemia (AML) who are unfit or have refused intensive chemotherapy. We expect this to occur between the second half of 2015 and the first half of 2016. As we continue study follow-up, we have begun preparations for submission of a Pediatric Investigation Plan to the European Medicines Agency. In parallel with sapacitabine activities, we are progressing development of CYC065, our novel, second-generation cyclin dependent kinase 2/9 inhibitor. Following submission of our Investigational New Drug application, we have received clearance from the FDA to begin a first-in-human, Phase 1 clinical trial of CYC065, which will commence following institutional review board approval. We have cash resources for the next two years which are sufficient to advance these programs and deliver on our key milestones," said CEO Spiro Rombotis.

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