CV Therapeutics Shares Rise Despite Angina Drug's Stumble
Dow Jones, Wednesday, December 10, 2003 at 12:43
By Amy Braunschweiger
Of Dow Jones Newswires
NEW YORK --Shares of CV Therapeutics Inc. (CVTX) advanced Wednesday even though its angina drug, Ranexa, stumbled before a regulatory panel as expected.
Late Tuesday, the Cardiac and Renal Drugs Advisory Committee to the Food and Drug Administration adjourned without making a recommendation on Ranexa. The nondecision didn't come as a surprise to many people -- a day earlier FDA staff published an analysis saying more clinical trials were needed before Ranexa could be approved.
But at least one Wall Street firm was putting a positive spin on the FDA panel's actions. Others urged investors to avoid the stock."This outcome, as well as the general tenor of the panel, was much more positive than the tone of the FDA briefing documents published Dec. 8,"U.S. Bancorp Piper Jaffray analyst Thomas Wei said in a note.
Although CV Therapeutics will need to submit more clinical data on the drug and show how it works on women and underrepresented ethnic minorities, Mr. Wei said he still expects approval for Ranexa in the second half of 2006.
The analyst noted that five of the 11 members of the FDA panel had voted to approve the drug outright, while the other six asked for additional data. Of those wanting more information on the drug, some said the Ranexa was"close to approval,"Mr. Wei said.
Around 12:30 p.m. EDT, in trading on the Nasdaq Market, shares of CV Therapeutics traded at $13.49, up $1.27, or 10% on volume of 9.2 million, sharply higher than average daily volume of 1.6 million shares. Monday, when the FDA released its more negative report on Ranexa, the company's stock dropped more than 20%, hitting a 52-week low of $12.20.
Bear Stearns analyst Akhtar Samad wrote in a note that before CV Therapeutics receives approval for Ranexa, the company will need to conduct a study potentially involving 200 to 800 patients that will take one to two years to complete.
The drug won't be approved before 2006, Dr. Samad believes.
The analyst cut his rating on the stock to"underperform"from"peer perform"as he sees no near-term catalyst to move shares higher. He believes much of the bad news related to Ranexa is priced into the stock.
A company representative wasn't immediately available for comment.
Neither Dr. Samad nor U.S. Bancorp's Mr. Wei was available to say whether they personally own shares of the company.
Both Bear Stearns and U.S. Bancorp seek an investment-banking relationship with CV Therapeutics. |
