According to a press release dated December 2, 2011, the Complaint alleges that, during the Class Period, the Company made false and/or misleading statements and/or failed to disclose material facts about a new drug. Specifically, the Company failed to disclose that the new drug was not approvable by the U.S. Food and Drug Administration due to chemistry, manufacturing, and control deficiencies that caused inconsistent results during laboratory tests.
On June 24, 2011, the Company announced that the Company had received a Complete Response Letter from the FDA on the New Drug Application for the new drug. As a result of this revelation, shares declined $3.94 per share or nearly 43%, to close at $5.30 per share on June 24, 2011.
On June 27, 2011, the Company disclosed that the FDA’s Complete Response Letter raised concerns related to, among other things, the chemistry, manufacturing, and controls sections of the NDA for the new drug. As a result of this revelation, shares declined an additional $1.37 per share or nearly 26%, to close at $3.93 per share on June 27, 2011.
On April 6, 2012, the Court issued an Order appointing lead plaintiff and approving the selection of lead counsel.
On June 8, 2012, Plaintiffs filed an Amended Complaint.
On September 25, 2012, the Court issued an Order granting the defendants' motion to dismiss without prejudice. Plaintiffs were giving 20 days to file an amended complaint. On October 15, 2012, the Plaintiffs filed their amended complaint.
On November 19, 2012, the Court issued an Order denying the defendants' motion to dismiss.
On August 30, 2016, the parties entered into a Stipulation of Settlement. The Settlement was preliminarily approved by the Court on September 1.