Biotech drug developer Dendreon Corp. said Tuesday that the Food and Drug Administration will grant a priority review for the company's prostate cancer drug.
A priority review means that the FDA will make a decision on the treatment within six months rather than the standard 10 months. The company submitted its marketing application in November, so now it expects the agency to render a decision by May 15.
Dendreon seeks approval for Provenge to treat asymptomatic, metastatic, androgen-independent prostate cancer, also known as hormone-refractory prostate cancer that has spread to other parts of the body.
Shares of Dendreon rose 32 cents, or 7.6 percent, to $4.55 in electronic premarket activity, after closing at $4.23 Friday on the Nasdaq Stock Market. Shares have traded between $3.68 and $5.77 over the past 52 weeks.
Prostate cancer is the most common non-skin cancer in the United States, with more than 1 million men living with the disease. An estimated 232,000 new cases are diagnosed each year in the U.S., and more than 30,000 men die each year of the disease.
In July, the company published data showing that Provenge enabled men with prostate cancer to live longer.
A priority review means that the FDA will make a decision on the treatment within six months rather than the standard 10 months. The company submitted its marketing application in November, so now it expects the agency to render a decision by May 15.
Dendreon seeks approval for Provenge to treat asymptomatic, metastatic, androgen-independent prostate cancer, also known as hormone-refractory prostate cancer that has spread to other parts of the body.
Shares of Dendreon rose 32 cents, or 7.6 percent, to $4.55 in electronic premarket activity, after closing at $4.23 Friday on the Nasdaq Stock Market. Shares have traded between $3.68 and $5.77 over the past 52 weeks.
Prostate cancer is the most common non-skin cancer in the United States, with more than 1 million men living with the disease. An estimated 232,000 new cases are diagnosed each year in the U.S., and more than 30,000 men die each year of the disease.
In July, the company published data showing that Provenge enabled men with prostate cancer to live longer.

0 Comments:
Post a Comment
Subscribe to Post Comments [Atom]
<< Home