According to a press release dated February 1, 2012, the Complaint alleges that, throughout the Class Period, the Company conditioned investors to believe that the Company's product, a gel intended to prevent preterm births in women with short cervices, would receive FDA approval through a host of materially false and misleading statements regarding the safety and efficacy of the product, as well as reportedly positive results from clinical trials.
On January 17, 2012, the FDA published information ahead of a meeting by the Advisory Committee for Reproductive Health Drugs of the FDA scheduled for January 20, 2012. The FDA documents revealed that the product did "not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks of gestation among women with a short cervical strength." Moreover, the safety of the gel was similar to a placebo as "[n]o maternal deaths occurred and the rates of fetal, neonatal and infant deaths were similar in both treatment arms." As a result of this revelation, the Company’s shares declined $1.305 per share or more than 54%, to close at $1.095 per share on January 17, 2012.
On May 9, 2012, the Court issued an Order consolidating cases, appointing lead plaintiffs, and approving the selection of lead counsel. On June 8, the plaintiffs filed their consolidated and amended complaint.
On June 11, 2013, the Court issued an Order granting the Defendants' Motion to Dismiss. Plaintiffs were given leave to file an amended complaint.
On July 11, 2013, the plaintiffs filed their consolidated second amended complaint.
On October 21, 2013, the Court issued an Order granting defendants' Motions to Dismiss. Plaintiffs may make a motion seeking leave to file an amended complaint. Plaintiffs declined to file an amended complaint, thus the Court issued an Order dismissing this case with prejudice on December 2, 2013. This Order was appealed by the Plaintiffs on December 20th.