Lawsuit Overview
January 29, 2015 - The U.S. Court of Appeals for the Ninth Circuit affirmed the decision of the district court.
October 26, 2012 - The lead plaintiff filed a notice of appeal.
September 27, 2012 - The court granted the defendants' motion to dismiss and dismissed the action with prejudice.
December 30, 2011 - The defendants filed a motion to dismiss.
November 9, 2011 - The lead plaintiff filed an amended complaint.
October 13, 2011 - The court granted the defendants' motion to dismiss and granted plaintiff leave to file an amended complaint.
June 3, 2011 - Defendants filed a motion to dismiss.
April 4, 2011 - The lead plaintiff filed an amended complaint.
February 2, 2011 - The lead plaintiff and lead counsel were appointed.
January 3, 2011 - Lead plaintiff motions were filed
November 2, 2010 - An investor in shares of Vivus Inc (NASDAQ: VVUS) filed a lawsuit in the U.S. District Court for the Northern District of California against Vivus Inc over alleged violations of Federal Securities Laws in connection with certain allegedly false and misleading statements made between September 9, 2009 and July 15, 2010 about its New Drug Application with the Food and Drug Administration for Vivus Inc product Qnexa as an obesity drug.
Vivus Inc's 12 month Total Revenue went from $102.23 million in 2008 to $50.04 million in 2009. Vivus Inc's Net Loss went from $9.94 million in 2008 to $54.29 million in 2009. For the first two quarters in 2010 Vivus Inc reported total revenue of $1.73 million, respectively $3.90 million with a Net Loss of $18.82 million, respectively $22.76 million. One of Vivus Inc's products is Qnexa®, which is an experimental drug hat has completed Phase III clinical trials for the treatment of obesity. According to Vivus Inc Qnexa is an investigational, once a day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety - the two main mechanisms that impact eating behavior.
In December 2009, Vivus Inc submitted a New Drug Application ( NDA ) to the Food and Drug Administration ( FDA ) to have Qnexa approved as an obesity drug. According to the complaint the plaintiff alleges on behalf of purchasers of the common stock of Vivus Inc (NASDAQ: VVUS) between September 9, 2009 and July 15, 2010, that Vivus Inc and certain of its officers and executives violated the Securities Exchange Act of 1934 by issuing between September 9, 2009 and July 15, 2010 false and misleading statements about Vivus Inc's weight loss drug Qnexa. On July 15, 2010, the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA held a hearing to review Qnexa and Vivus Inc announced that it voted against recommending Qnexa.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted in the negative on the question of whether the overall risk-benefit assessment of Qnexa is favorable to support its approval for the treatment of obesity. When news of the vote was publicly announced on July 15, 2010, the market price of Vivus Inc common stock declined, falling $6.70 per share, or 55%, to $5.41 per share. Shares of Vivus Inc continued declined to $5.07 per share on August 11 but then increased over the next months to over $8 on October 29, 2010. Even though the vote from the Endocrinologic and Metabolic Drugs Advisory Committee was only recommendation on October 28, 2010 Vivus Inc had to announce after the market closed that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for QNEXA and that the FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form. Vivus Inc (NASDAQ: VVUS) shares declined since then to $7.12 on Friday November 5, 2010.
Mountain View, California based Vivus Inc is a biopharmaceutical company focused on the development and commercialization of therapeutic products for underserved markets.