Reuters
Dendreon jumps as FDA eyes prostate cancer drugs
Tuesday June 22, 4:36 pm ET
By Ransdell Pierson and Bill Berkrot
NEW YORK, June 22 (Reuters) - Shares of Dendreon Corp. (NasdaqNM:DNDN - News) jumped on Tuesday on hopes U.S. regulators will ease criteria for approving prostate cancer medicines, and thereby eventually make its experimental treatment available to more patients, analysts said.
Expectations on Wall Street that a large drug maker this summer will agree to co-market Dendreon's medicine, called Provenge, also spurred the rise in the stock, analysts said.
Shares of Seattle-based Dendreon closed up 98 cents, or 8.9 percent, to $12.01, in heavy trade on the Nasdaq.
The U.S. Food and Drug Administration was holding a workshop on Tuesday to formulate strategy on possible alternative standards the agency could use to gauge the effectiveness of drugs to treat prostate cancer, the second most common cause of cancer death among men.
The workshop is one of a series the agency is holding on goals, or endpoints, of cancer-drug trials. Earlier this year the FDA looked at lung and colon cancer endpoints.
Dendreon's lead product is now in late-stage trials for patients with the disease whose cancer has spread despite treatments that lower their levels of testosterone, the male hormone that feeds the growth of the cancer.
The Phase III trial is designed to show a survival benefit among patients, as well as delay in progression of symptoms, such as pain that develops in the bones as the cancer spreads.
Delafield Hambrecht analyst Quynh Pham said investors are hoping the FDA workshop may lead the agency to eventually accept less-stringent goals for prostate cancer trials, such as control of a protein called prostate-specific antigen that is present in high levels among many men with the disease.
"If that were to happen, Provenge might eventually be deemed appropriate for patients in earlier stages of prostate cancer," said Pham, who noted that the drug is now expected only to be approved for patients with late stage disease.
She said it would take far less time to conduct trials based on so-called "surrogate endpoints" such as PSA levels than conventional trials based on survival, that can last five to 10 years.
Mark Monane, a biotech analyst for Needham and Co., said the FDA workshop had put a spotlight on Provenge and other treatments for the disease.
"Clearly the FDA is trying to clear any muddy waters that exist for therapeutics in this area," Monane said.
Monane and other analysts said Dendreon shares also were helped by expectations the company will choose a marketing partner for Provenge in the third quarter.
"People are thinking about what's coming up next quarter and they may be saying 'a partner for Provenge'" said Paul Keough of Next Generation Equity Research.
Dendreon officials could not be reached for comment. (Additional reporting by Lisa Richwine in Washington)
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es scheint von der FDA ein großes Interesse an HRPC-Therapien zu geben...
übrigens hat DNDN aktuell eine MK von 674 Mio USD, was nach der KE einem GPC-Kurs von etwa 19,28 EUR entspricht...
mfg ipollit
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