Originally published November 2, 2009 at 9:43 AM | Page modified November 2, 2009 at 4:50 PM
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Dendreon completes FDA submission for cancer drug
Dendreon said Monday that it completed its Food and Drug Administration application for the potential cancer drug Provenge. The drug is aimed...
Dendreon said Monday that it completed its Food and Drug Administration application for the potential cancer drug Provenge.
The drug is aimed at treating prostate cancer. It works as a vaccine to stimulate the body's immune system so it fights the cancer, but is given as a treatment rather than a preventive. The application is ahead of the company's prior timeline for 2010.
"With the BLA (Biologics License Application) submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," said President and CEO Dr. Mitchell H. Gold said in a statement.
The company has previously said it hopes to gain FDA approval and launch the drug in 2010.
Shares of Dendreon initially rose as much as $1.61 in early trading Monday before giving up much of their gains; the stock closed up 13 cents at $25.40 The shares have traded between $2.55 and $30.42 over the past 52 weeks.
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