Dendreon: IMPACT data reported, uncertainty removed Yesterday (April 28), Dendreon Corp. (DNDN) shares swung widely before the final data of IMPACT trial were reported. Share price of this tiny biotech company rose as high as $25 and then declined to as low as $7.5 per share, which prompted a brief probe and trade halt by the NASDAQ market oversight body.We believe the wild ride reflected investors' nervousness about the data of the company's phase III IMPACT trial for Provenge. At 2 pm ET yesterday, Dendreon reported detailed data at the American Urological Association (AUA) Annual Meeting held in Chicago. Key findings from the trial include:Provenge extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months). Provenge improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%). The IMPACT study achieved a p-value of 0.032, successfully ...

Just wait until the opening bell starts ringing Wednesday, Dendreon (NASDAQ:DNDN) will be counting their money like Nino Brown from a high-rise penthouse on Cloud 9.  Provenge is a winner and appears to be on its way to become the first approved therapeutic vaccine for any type of cancer. Dendreon shares were halted after they plunged 45% in a two-minute span to $11.81 on Nasdaq in the hour leading up to release of the study results. When trading resumed after hours, the shares rose 130% to a new record high of ...

I wish I could say I never heard of Dendreon (DNDN) before today, but a reader was good enough to email me about this stock not even a month ago in the $3s. As a general rule, except for some of the really huge biotech stocks, I stay away from these type of names – the stock market is difficult as it is, and small cap biotech stocks make the normal stock market gambling look like child’s play. Of course after today’s news I wish I had investigated further. Outside of the stock reaction, it is hopefully a promising new turn in medicine.

Reuters – Dendreon Cancer Vaccine Works

An experimental medicine from Dendreon Corp improved survival in men with advanced …

Positive IMPACT trial results will likely lead to Provenge approval by the FDA in 1H10This morning, Dendreon Corporation (DNDN) announced results of the long-awaited pivotal phase III IMPACT study of Provenge in men with advanced prostate cancer. In the news release and the conference call, management disclosed that the phase III study met its primary endpoint of improving overall survival compared to a placebo. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of Provenge appeared to be consistent with prior trials.As a reminder, Dendreon's lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine. Previous two phase III studies ...

Shares of Dendreon Corp. (DNDN) jumped 38 percent last Friday and another 13% in early morning trading today. However, we don't see any clear rationale for the rally at this point of time. We believe investors are looking ahead to long-awaited data on the company's experimental Provenge vaccine to treat advanced prostate cancer, but we are cautious about the final results anticipated by the end of April. As a reminder, Dendreon's lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine.Previous two phase III studies generated mixed results. Study D9901 showed that Provenge approached, but did not meet its primary end point of showing a significant delay in time to disease progression (p=0.052, HR=1.4). However, Provenge showed a statistically significant median survival benefit (secondary endpoint) in ...

A good balance sheet and a couple of of late-stage hormone therapy products underlie recently appointed CEO Dr. David Mazzo’s enthusiasm for the future prospects of the 16-year-old, Quebec-based biopharmaceutical firm Æterna Zentaris