On or around 08/07/2015 (Notice of voluntarily dismissal)
Filing Date: February 02, 2015
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.
Company & Securities Information
Defendant: Venaxis, Inc.
Industry: Medical Equipment & Supplies
Headquarters: United States
Ticker Symbol: APPY
Company Market: NASDAQ
Market Status: Public (Listed)
About the Company & Securities Data
"Company" information provides the industry and sector classification and headquarters state for the primary company-defendant in the litigation. In general, "Securities" information provides the ticker symbol, market, and market status for the underlying securities at issue in the litigation.
In most cases, the primary company-defendant actually issued the securities that are the subject of the litigation, and the securities information and company information relate to the same entity. In a small subset of cases, however, the primary company-defendant is not the issuer (for example, cases against third party brokers/dealers), and the securities information and company information do not relate to the same entity.