were getting knocked around again following some ambiguous communication from the Food and Drug Administration about its angina candidate, Ranexa.
The biotechnology company said in a release that it had received an "approvable letter" from the agency, but added that its new drug application currently contains insufficient information for approval, according to the FDA.
"In the approvable letter, the FDA indicated that there is evidence that Ranexa is an effective anti-anginal, and that additional clinical information is needed prior to approval," the company said.
That sent shares down $5.86, or 26%, to $16.87 on unusually heavy trading volume, making them the second-biggest decliner on the
. More than 7 million shares had changed hands, about seven times normal volume.
It's a brutal turnaround from just one week ago, when CV Therapeutics shot up 25% on news that an FDA advisory committee had scheduled a Dec. 3 hearing to review the drug.
To complicate matters, the company said the FDA may be prepared to re-evaluate whether the NDA is in fact insufficient based on the outcome of the Dec. 3 hearing.
Before the markets opened, CIBC World Markets downgraded the shares from sector outperform to sector perform.
CV shareholders are used to volatility. On Aug. 4, the same committee canceled a review of the drug that had been scheduled for September. The panel said at the time it wouldn't have time to adequately prepare for the meeting.
That news sent the shares down 28% to about $25.50, a level from which they'd steadily fallen until last Thursday.