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BIOTECH REPORT Panel asks for more data on heart drug CV Therapeutics hits snag in effort to win OK for Ranexa By Ted Griffith, CBS.MarketWatch.com Last Update: 5:20 PM ET Dec. 9, 2003 BOSTON (CBS.MW) -- In a setback for CV Therapeutics, a Food and Drug Administration advisory panel on Tuesday asked for more studies of the biotechnology firm`s experimental treatment for a heart condition. The advisory panel found that the FDA should ask for more research before deciding whether to approve the company`s Ranexa drug, Reuters reported. Additional studies of Ranexa, which treats the painful heart condition angina, could significantly delay approval of the drug. The final decision is up to the FDA, but the agency typically follows the recommendations of its advisory panels, which are made up of outside medical experts. Trading in shares of Palo Alto, Calif.-based CV Therapeutics (CVTX: news, chart, profile) were halted Tuesday morning. They last traded at $12.22. A company spokeswoman didn`t immediately return a call seeking comment. Ranexa is CV Therapeutics` lead product candidate. The company has no products on the market. CV Therapeutics shares had been under pressure ahead of the FDA review. On Monday, shares plunged 27 percent after documents posted by the FDA on the agency`s Web site renewed concerns about a cardiac side effect associated with Ranexa. The FDA in the documents released Monday said studies appeared to show that the drug was linked with a heart rhythm side effect. The side effect, known as QT prolongation, can be an indication of a developing heart arrhythmia, a potentially life-threatening condition. Ahead of the panel meeting, analyst Thomas Wei at US Bancorp Piper Jaffray predicted Ranexa wouldn`t reach the U.S. market until the second half of 2006. The analyst, in a note to clients, projected peak sales of the drug would eventually exceed $300 million. CV Therapeutics` shares had also plunged in late October after the company first said the FDA had indicated further studies may be needed before the drug wins final approval. At the same time, the FDA granted Ranexa conditional approval status and said the drug appeared to be effective. Ted Griffith is a reporter for CBS.MarketWatch.com |
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| aus der Diskussion: | +++ CV Therapeutics Inc (CVTX) - Kurssturz +++ |
| Autor (Datum des Eintrages): | kosto1929 (10.12.03 00:21:06) |
| Beitrag: | 51 von 470 (ID:11563126) |
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