LOS ANGELES--(BUSINESS WIRE)--Glancy Binkow & Goldberg LLP announces that a class action lawsuit has been filed in the United States District Court for the District of Colorado on behalf of a class (the “Class”) comprising purchasers of the securities of Venaxis, Inc. (“Venaxis” or the “Company”) (NASDAQ:APPY) between March 13, 2014 and January 28, 2015, inclusive (the “Class Period”).
Please contact Casey Sadler at (888) 773-9224 or (310) 201-9150, or at shareholders@glancylaw.com to discuss this matter. If you inquire by email please include your mailing address, telephone number and number of shares purchased.
Venaxis develops and commercializes products for unmet diagnostic and therapeutic needs. The Company’s lead product candidate is APPY1 − a blood-based diagnostic test designed to aid in the evaluation of patients for acute appendicitis. The Complaint alleges that defendants made false and/or misleading statements and/or failed to disclose that: (1) the APPY1 test failed to meet the criteria for “substantial equivalence” based upon data and information submitted by Venaxis in its 510(k) premarket submission to the U.S. Food and Drug Administration; (2) the Company lacked a reasonable basis to conclude that the results from the APPY1 pivotal study were sufficient to support FDA clearance; and as a result of the foregoing, (3) Venaxis’ public statements pertaining to the expected FDA clearance of its 510(k) were materially false and misleading at all relevant times.
On January 29, 2015, the Company announced that the FDA has determined that the Company’s appendicitis test was not found to be substantially equivalent to the standard of care. According to the Company, the FDA determined that “the APPY1 Test does not meet the criteria for substantial equivalence based upon data and information submitted by Venaxis in its 510(k) submission.” Following this news, Venaxis shares dropped more than 73%, or $1.49 per share, to close at $0.55 on January 29, 2015, on extremely heavy volume.
If you are a member of the Class described above, you may move the Court no later than April 3, 2015, to serve as lead plaintiff, if you meet certain legal requirements. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Casey Sadler, Esquire, of Glancy Binkow & Goldberg LLP, 1925 Century Park East, Suite 2100, Los Angeles, California 90067, at (310) 201-9150, by e-mail to shareholders@glancylaw.com, or visit our website at http://www.glancylaw.com. If you inquire by email, please include your mailing address, telephone number and number of shares purchased.
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