Dendreon Says FDA Would Accept Interim Data On Provenge

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Dow Newswires - May 31, 2007 10:59 AM ET

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NEW YORK (Dow )--Dendreon Corp. (DNDN) Thursday said the Food and Drug Administration would accept interim trial data to meet the regulator's request for additional information on the prostate cancer drug Provenge, sending the company's shares sharply higher. The surge in the Seattle company's stock price reflects investors' optimism that the cancer treatment - for which some project worldwide sales of more than $1 billion - may reach the market before final data is expected to be released in 2010. "The FDA indicated that either a positive interim or final analysis of survival...would address their request for the submission of additional clinical data in support of our efficacy claim," Chief Executive H. Gold said in a press release. He added that the company expects to finish enrollment in the IMPACT study this year and sees interim survival results next year. Shares of Dendreon were recently up $2.83, or 42%, at $9.57, with more than double the average daily volume of shares traded. Shares traded as much as 93% higher earlier Thursday. Provenge is the first so-called active cellular immunotherapy drug, which tries to fight cancer by harnessing the body's immune system. Current treatments attack the cancer cells directly. Earlier this month, the FDA requested more clinical to support the effectiveness of the drug, which sent Dendreon shares plunging 60%. That followed an FDA panel recommendation in March after which the company's stock price more than doubled. At the time of the March meeting, nearly 33% of Dendreon's float was sold short, as many doubted the treatment's chances for approval. That number has since risen to 51% based on the latest figures available, which are through May 15, according to FactSet Research. See what's free at AOL.com.