CV Thera's Ranexa fails in ACS study

Californian drugmaker CV Therapeutics says that its heart drug Ranexa (ranolazine) has failed to achieve the primary efficacy endpoint in a study assessing it as a treatment for acute coronary syndrome. The company added, however, that no adverse trend in deaths, arythmias or abnormal heart rhythms had been observed during the trial.

Ranexa is currently approved as a second-line treatment for chronic angina in patients who have not responded to alternate therapies, but is limited by its labeling which cautions against a possible increase risk of arythmias. The firm said believes that the safety data could be used to support expansion of the drug's labeling to include the first line treatment of angina, in accordance with the Food and Drug Administration's special protocol agreement.

The company's share price tumbled 26% to $12.30 in after hours trading on the New York Stock Exchange on the day of the news, March 6.