Buckle up, Dendreon Corp. watchers. The Seattle biotech firm's thrill ride from ecstasy to misery and back continues with Thursday's news. To approve Dendreon's prostate cancer treatment Provenge, the Food and Drug Administration will only require a few months' worth of extra data, not the two or three years that investors feared when the feds sent Dendreon the dreaded "approvable" letter earlier this month. (In FDA-speak, "approvable" means "not yet approvable." Go figure.)
For those of you who've missed the rollercoaster, here's a recap. An FDA advisory panel gave Provenge a thumbs-up in March, a sign that the agency was likely to approve the drug, despite less-than-spectacular trial data. Provenge is meant for patients with prostate cancer that has spread to other parts of the body and no longer responds to traditional therapy. From $5 per share, the stock reached a high of $25 apiece on April 10. But the FDA had other plans, notifying Dendreon in May that it needed more data. The stock sank back to the single digits.
Then comes Thursday's news that the FDA only needs interim data from a study that's starting this year. It means the drug could be approved and on the market in 2008, instead of 2010. With the rise in stock price, up 33% to $8.96 in late-day trading, Dendreon is in better shape to raise more cash, which executives earlier this month said was probably necessary to pay for expensive clinical studies.
Dendreon's not yet out of the woods. The company laid off 40 employees recently to save money, and it's unclear whether or not the firm can ramp back up quickly when (or if) Provenge is approved. The firm may have to turn to a licensing deal, in which Dendreon finds a Big Pharma partner to help with the final push to market in one or more of the major world markets.—Alex Lash
See story from The Wall Street Journal
See May 11, 2007 story from TheDeal.com
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