Dendreon’s long-awaited big news is coming tomorrow morning. The Seattle biotech company (NASDAQ: DNDN) said it will hold a conference call before stock trading opens tomorrow morning to discuss the final results of a clinical trial that will show whether its immune-stimulating drug for prostate cancer, Provenge, can help men live longer.
The company’s conference call will start at 9 am Eastern time/6 am Pacific, about a half-hour before trading opens. The company didn’t tip its hand one way or another in its statement today, but it’s important enough that trading was halted in the stock prior to the announcement. Plenty of people are already betting big that Dendreon is going to have positive results from this trial, called Impact, of 500 with terminal prostate cancer. Shares climbed 16 percent today to close at $7.30, on about quadruple the average trading volume.
This announcement will be the culmination of a clinical trial that began six years ago, and may also be the climax to one of the best-known sagas in the biotech industry, as I described in this in-depth recap on April 3. Provenge showed an ability to prolong lives a median time of about 4.5 months in one study of 127 men in 2005, and Dendreon tried to win FDA approval based on that study. But in May 2007, the FDA said that wasn’t enough, and it wanted to see whether the results could be confirmed in the larger trial of 500 men, called Impact, which was already underway. This trial was unable to show a convincing enough survival advantage back in October when a board of clinical trial monitors took an early peek, but the data showed Dendreon was within striking distance of its goals for this final upcoming analysis.
As a reminder, the company needs to show a 22 percent lower risk of death for men on Provenge, compared to those on a placebo. If it clears that bar, the company will whip up its application to the agency as soon as possible. Analysts will remind investors that this drug has $1 billion a year in sales potential, and the stock will likely boom to more than $20 a share if the news is good, says analyst David Miller. If the FDA approves Provenge, it would be Dendreon’s first marketed product. If the trial fails, Dendreon will probably put its promising immune-boosting technology on the back burner and resort to layoffs, Miller says.
It’s time to get on the edge of your seats. Tomorrow will be an early morning for those of us on the West Coast. The dial-in number is 877-419-6594 or you can catch the webcast at www.dendreon.com on the investor relations section.
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