CASES
Columbia Laboratories, Inc.
Class Period: Dec 6, 2010 to Jan 20, 2012
Lead Plaintiff Deadline: Apr 2, 2012 + Deadline passed
Summary of Case:
A securities class action has been filed against Columbia Laboratories, Inc. ("Columbia" or the "Company") on behalf of all persons who purchased Columbia securities from December 06, 2010 through January 20, 2012. This case has been filed in the USDC - New Jersey.
The Complaint alleges that, throughout the Class Period, Columbia conditioned investors to believe that the Company's PROCHIEVE progesterone vaginal gel 8% ("PROCHIEVE 8%"), 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 PROCHIEVE's 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 ("Advisory Committee") scheduled for January 20, 2012. The FDA documents revealed that PROCHIEVE 8% 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, Columbia shares declined $1.305 per share or more than 54%, to close at $1.095 per share on January 17, 2012.
On January 20, 2012, the Advisory Committee voted 13 to 4 not to recommend approval of PROCHIEVE 8%, as the risks of the progesterone gel outweighed the benefits.
As a result, Columbia's shares declined an additional $0.874 per share or more than 55%, to close at $0.706 per share on January 23, 2012.
If you purchased this company's shares during the Class Period and suffered a loss or for further information about the case, please review the links below.