A class action has been filed against biopharmaceutical company CV Therapeutics, Inc. (Nasdaq: CVTX) and certain of its officers and directors by stockholders who purchased the company's common stock between May 14 and August 1, 2003. The action claims that the defendants violated federal securities laws by issuing a series of material misrepresentations about the company's New Drug Application for Ranexa, a drug for the treatment of chronic angina, to the market over this time period, thereby artificially inflating the price of the company's securities. The stockholders seek to recover compensatory damages for the loss of value of their stock.

The action claims that the true facts were as follows:

1. The required regulatory assessment of safety and efficacy requirements for Ranexa was deficient.

2. Due in part to a major disruption and changes in the company's relationship with Quintiles Transnational Corporation, responsibility for and supervision of the clinical development program was in disarray.

3. Neither the defendants nor Quintiles possessed sufficient knowledge or experience to effectively deal with the QT interval prolongation or other safety issues facing Ranexa.

4. The clinical program for Ranexa was so defective that it prohibited, even with reasonable application of additional resources, the imposition of the required form or administrative requirements in the expeditious manner necessary to meet FDA deadlines for data presentation to the advisory committee.

5. CV Therapeutics misled the FDA into believing that the application and studies were in order for Ranexa as late as July 7, 2003, the date the FDA informed the company of the meeting.

6. The company misled the FDA into believing that it could prepare its briefing package for the Advisory Committee meeting by the deadline.

7. For one or more reasons related to unmet safety or efficacy requirements for the drug, the New Drug Application for Ranexa could not be approved as submitted.

8. The failure to disclose the defective nature of the early clinical program or other obstacles preventing the company from meeting the briefing package deadline would prevent investors from learning the extent of the misrepresentations made to them during the time period involved.

As a result of the defendants' allegedly false statements, CV Therapeutics stock traded at $37.80 on June 5, 2003, whereby the company sold $100 million worth of its own securities.