Lawsuit Overview
October 6, 2017 - The case was dismissed.
September 22, 2017 - The court granted defendants' motion to dismiss.
November 8, 2016 - A motion to dismiss the amended complaint was filed..
September 26, 2016 - An amended complaint was filed.
June 2, 2016 - An investor in shares of Transenterix Inc (NYSEMKT: TRXC) filed a lawsuit in the U.S. District Court for the Eastern District of North Carolina over alleged violations of Federal Securities Laws by Transenterix Inc in connection with certain allegedly false and misleading statements made between February 10, 2016 and May 10, 2016.
On June 1, 2015, Transenterix Inc announced that it had submitted its 510(k) application to the United States Food and Drug Administration ( FDA ) seeking substantial equivalence approval that would enable TransEnterix Inc to begin marketing and selling the SurgiBot in the United States.
According to the complaint the plaintiff alleges on behalf of purchasers of Transenterix Inc (NYSEMKT: TRXC) common shares between February 10, 2016 and May 10, 2016, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between February 10, 2016 and May 10, 2016 the defendants allegedly failed to disclose deficiencies within the Company's 510(k) submission regarding the SurgiBot that undermined the likelihood that the SurgiBot would receive FDA clearance, which would leave the Company unable to commercialize the SurgiBot in 2016 and would impair the Company's ability to obtain approval for and commercialize its other robotic surgery platform in the United States and that as a result of these false statements and/or omissions, TransEnterix Inc common stock traded at artificially inflated prices February 10, 2016 and May 10, 2016, reaching as high as $5.69 per share.
On April 20, 2016, Transenterix Inc announced that the Food and Drug Administration ( FDA ) notified Transenterix Inc on April 19, 2016 of its determination that the SurgiBot™ System does not meet the criteria for substantial equivalence based upon the data and information submitted by TransEnterix in its 510(k) submission.” Shares of Transenterix Inc (NYSEMKT: TRXC) declined to a slow as $1.28 per share on April 21, 2016.