Dendreon's interim results from a trial of its prostate-cancer drug Provenge show mixed results, but stock soars anyhow.
Dendreon said Monday that Provenge demonstrably improved survival among prostate cancer patients, according to long-awaited interim results from a clinical trial.
The results sent Dendreon shares soaring, but were not strong enough for the company to ask federal regulators for speedier approval. Instead, the Seattle biotech firm will await the final analysis, scheduled for mid-2009.
The news is “not as good as it could have been, nor as bad as it could have been,” said Paul Latta, an analyst with McAdams Wright Ragen.
Dendreon shares traded at $6.93, up 33 percent, after jumping as high as $9 in early morning trading, against the dismal backdrop painted by a global financial shakeout.
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Provenge, Dendreon’s lead therapy, which would be the first commercial immunetherapy to fight cancer, if it is approved.
But it has been a roller-coaster ride for many investors. In early 2007 the company stock rode as high as $19 on hopes that the U.S. Food and Drug Administration would approve the product in May of that year.
But the agency decided to withhold approval, asking for more data instead. That triggered a sharp fall in the stock price and an angry response from prostate cancer patients eager for a promising treatment.
Hopes soared again when the FDA said it would look at the interim data presented today as sufficient to support an application for approval. But the data “did not meet the pre-specified criteria” for Dendreon to modify the marketing approval it has pending at the FDA, said Chief Executive Mitch Gold in a conference call.
In order to meet its goals, Dendreon needs to demonstrate a 22 percent reduction in the risk of death among patients using Provenge, based on 304 patients, the company said.
The final analysis of the data was originally due in 2010, but the last March company redesigned the clinical trial in order to fast-forwards the results by a year.
Ángel González: 206-515-5644 or firstname.lastname@example.org