Lawsuit Overview
August 7, 2015 - The lead plaintiffs filed a notice of voluntary dismissal without prejudice.
June 15, 2015 - Lead plaintiffs and lead counsel were appointed and all cases were consolidated.
April 3, 2015 - Lead plaintiff motions were filed.
February 2, 2015 - An investor in shares of Venaxis Inc (NASDAQ: APPY) filed a lawsuit in the U.S. District Court for the District of Colorado against Venaxis Inc over alleged violations of Federal Securities Laws in connection with certain allegedly false and misleading statements made between March 13, 2014 and January 28, 2015.
Venaxis Inc is an in vitro diagnostic company focused on developing and commercializing its lead product candidate, the APPY1 diagnostic test, which is designed to aid in the identification of patients at low risk for acute appendicitis.
According to the complaint the plaintiff alleges on behalf of purchasers of Venaxis Inc (NASDAQ: APPY) common shares between March 13, 2014 and January 28, 2015, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that Defendants allegedly made false and/or misleading statements and/or failed to disclose thatthe APPY1 test failed to meet the criteria for substantial equivalence based upon data and information submitted by Venaxis Inc in its 510(k) submission, that Venaxis Inc lacked a reasonable basis to conclude that the results from the APPY1 pivotal study were sufficient to support , the United States Food and Drug Administration ( FDA ) clearance; and as a result of the foregoing, and that Venaxis Inc’s public statements pertaining to the expected FDA clearance of its 510(k) submission were materially false and misleading at all relevant times.
On January 29, 2015, Venaxis Inc announced that, the FDA has 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. Its appendicitis test was not found to be substantially equivalent to standard of care by the U.S. health regulator. Shares of Venaxis Inc (NASDAQ: APPY) declined from $2.09 per share on January 28, 2015 to as low as $0.41 per share on February 2, 2015.