Review Date Is Big News for CV Therapeutics

Updated from 2:28 p.m. EDT

CV Therapeutics ( CVTX) was the biggest gainer on the Nasdaq Thursday after the FDA scheduled an advisory group hearing on its angina candidate Ranexa.

The shares surged $6.20, or 34%, to $24.42 on about four times their normal volume after the FDA's Cardiovascular and Renal Drugs Advisory Committee scheduled the review for Dec. 9, 2003.

"It's an extremely important development for the company since this is by far the most advanced product they have, the first in a new class of drugs and there is no competition in this class so far," said David Webber, analyst at First Albany, who has a buy rating on the stock. First Albany currently does not own the stock or have any banking relationships with the company.

Webber estimates the more than 6 million patients who suffer from chronic angina in the U.S. represent a $400 million to $500 million market for CV Therapeutics.

"The odds favor the approval of the drug based on its efficacy in decreasing the frequency of angina attacks and prolonging the patients' exercise time on the treadmill," said Webber.

CV Therapeutics shares had a correspondingly bad day on Aug. 4 when 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 Thursday. Short interest in the stock is about 17% of its float, though it's likely some of that interest was being chased out in the latest rally.

CV Therapeutics, a biopharmaceutical company based in Palo Alto, Calif., submitted a new drug application for Ranexa to the FDA last December. If approved, Ranexa would represent the first new class of antianginal therapy in the U.S. in more than 20 years.

Advisory groups are the FDA's primary forum for drug evaluation. Their recommendations aren't binding on the parent agency but are almost always followed.

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