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September 27, 2012
07:30 EDTAPPYAspenBio Pharma plans to initiate pivotal study in Q4 following FDA meeting
AspenBio Pharma provided its shareholders and the broader investment community with an update on its clinical and business activities. The Company announced that it plans to initiate a pivotal study in the fourth quarter of 2012 for its blood-based appendicitis test designed to assist emergency room clinicians in ruling out acute appendicitis. The Company is moving ahead with its plans following its recent productive meeting with the U.S. Food and Drug Administration. In addition to seeking approval in the U.S., the Company plans to obtain CE Mark before the end of the year and to introduce the product in Europe shortly thereafter. In addition to the Company's clinical advancements, AspenBio announced that progress continues for its out-licensed animal health assets. To date, cumulative consideration achieved under the exclusive license agreement is approximately $1.3M, including license fees and milestone payments.
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October 27, 2014
18:26 EDTAPPYOn The Fly: After Hours Movers
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16:38 EDTAPPYVenaxis up 3% following presentation of APPY1 trial data
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16:37 EDTAPPYVenaxis presents APPY1 trial results
Venaxis announced the company's pivotal APPY1 Test clinical trial data were presented at the American College of Emergency Physicians Scientific Assembly 2014. The clinical trial involved 29 U.S. hospital sites recruiting patients aged 2 20 from January 2013 through January 2014. Results were presented by Lead Principal Investigator Dr. David S. Huckins, M.D. 1887 patients aged 2 to 20 years with suspected acute appendicitis were included in the study. The results of the study showed the APPY1 Test exhibited a sensitivity of 96.9%, a negative predictive value of 97.3%, a negative likelihood ratio of 0.08, and a specificity of 37.8% for acute appendicitis. Prevalence of disease was 25.3%. The APPY1 Test correctly identified 533 of 1409 patients who did not have appendicitis with 15 false negatives among 478 patients with acute appendicitis. Among patients without appendicitis, 32% who underwent a computed tomography were correctly identified by negative APPY1 Test results. The APPY1 Test is under FDA review and is currently not available for sale in the U.S.

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