CASES
Vivus, Inc. (2010)
Class Period: Sep 9, 2009 to Jul 15, 2010
Lead Plaintiff Deadline: Jan 3, 2011 + Deadline passed
Summary of Case:
A securities class action has been filed against Vivus, Inc. (2010) (VVUS) ("Vivus" or the "Company") on behalf of all securities purchasers from September 9, 2009 through July 15, 2010, inclusive ("Class Period"), in the United States District Court for the Northern District of California.
The complaint alleges that during the Class Period, defendants made false and misleading statements about the Vivus's weight loss drug Qnexa® ("Qnexa" or the "drug"). More specifically, the Company failed to disclose that: (a) the studies conducted by Vivus and submitted to the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA (the "FDA Panel") could not support FDA Panel approval for Qnexa's use to treat obesity as a chronic condition, and, at the very least, longer-term clinical studies would be needed to determine whether Qnexa was safe for its intended use to treat chronic obesity; (b) the trial results showed worrisome adverse effects of the type that scuttled approval for other obesity drugs, including: increased risk of suicide, cardiovascular events, and birth defects; (c) four to seven times as many patients taking the highest dose of Qnexa, compared to patients taking lower doses or placebos, dropped out of the study because of adverse side effects such as anxiety, sleep disorders, or depression; and (d) Qnexa would likely receive a "Pregnancy Category X" label from the FDA due to risks of birth defects (teratogenicity), instead of the proposed "Pregnancy Category C" label, thereby potentially eliminating a huge swath of potential Qnexa customers.
On July 15, 2010, the FDA Panel held a hearing to review Qnexa. Following the lengthy review and discussion, the FDA Panel voted against recommending Qnexa based on concerns regarding adverse effects and the unknown impact of long-term use beyond the 56-week clinical study period. The FDA Panel voted 10-to-6 in the negative on the question of whether the "overall risk-benefit assessment of Qnexa is favorable to support approval." When news of the vote was publicly announced on July 15, 2010, the market price of Vivus common stock plummeted, falling $6.70 per share, or 55%, in one day on unusually high trading volume of over 42.3 million shares. On October 28, 2010, the FDA followed the recommendation of the FDA Panel and rejected Vivus's NDA for Qnexa.
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.