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March 13, 2014
07:10 EDTAPPYVenaxis' APPY1 test shows positive top-line results
Venaxis announced positive top-line results from its pivotal U.S. study of its CE Marked APPY1 Test, a multiple biomarker-based assay for identifying patients that are at low risk for appendicitis. The APPY1 Test performed well, with sensitivity and negative predictive value results that exceeded those from the previous pilot study. The company believes these pivotal results are sufficient for potential FDA clearance and expects to finalize its 510(k) submission and file with the FDA in the next few weeks.
News For APPY From The Last 14 Days
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January 29, 2015
14:43 EDTAPPYVenaxis downgraded to Hold from Buy at Craig-Hallum
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09:06 EDTAPPYOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Flextronics (FLEX), up 6%... Coach (COH), up 6.3%... Autoliv (ALV), up 4.3%... Dow Chemical (DOW), up 3.5%... Ford (F), up 0.8%. ALSO HIGHER: McDonald's (MCD), up 3% after announcing CEO change...Xencor (XNCR), up 19% after reporting results from two trials... Pluristem Therapeutics (PSTI), up 8% after providing update and outlook on trials and pipeline... Avon Products (AVP), up 2.3% after naming James Scully as CFO... Omeros (OMER), up 6% after 2.996M share spot secondary priced at $20.03. DOWN AFTER EARNINGS: Alibaba (BABA), down 8%... Qualcomm (QCOM), down 6.8%... Alexion (ALXN), down 1.1% after reporting fourth quarter results, fiscal 2015 guidance, and CEO appointment. ALSO LOWER: Yahoo (YHOO), down 7% following Alibaba earnings report... Venaxis (APPY), down 72% after its APPY1 Test was determined by the FDA to not meet the criteria for substantial equivalence.
06:46 EDTAPPYVenaxis' APPY1 Test 510(k) submission turned down by FDA
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