According to the law firm press release, Venaxis is a Colorado-based in vitro diagnostic company focused on developing and commercializing its lead product candidate, the APPY1 diagnostic test. The APPY1 test is designed to aid in the identification of patients at low risk for acute appendicitis.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the APPY1 510(k) submission and the Company's future prospects. Specifically, 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) submission; (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) submission were materially false and misleading at all relevant times.
On January 29, 2015, Venaxis issued a press release disclosing that "the United States Food and Drug Administration ("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."
As a result of this news, shares of Venaxis fell $1.49, or more than 73%, on extremely heavy volume, to close at $0.55 on January 29, 2015.
On August 7, 2015, this case was voluntarily dismissed by the Plaintiffs.