Just over two years ago the Dendreon (DNDN) stock soared to the mid twenties after an FDA advisory panel voted 17-0 that Provenge, Dendreon's prostate cancer immunotherapy, was safe and 13-4 that it was effective.
The rise in the stock price resulted in anticipation of the FDA approval that never came.
The FDA issued an approvable letter for Provenge, declaring that they needed more proof that Provenge worked.
That proof came today.
Dendreon reported that the Phase III IMPACT trial met it's primary endpoints of survival and that more information would be forthcoming at the American Urological Association's conference at the end of the month.
The DNDN stock closed at $16.99 today, up over 132% from yesterday's close, after reaching an intra-day high of $22.10.
Provenge still needs to clear the hurdle of commercial approval, but if the FDA maintains their previous stance, these trial results should be enough to garner that approval.
Today's trading rewarded patient investors, especially those that sold into the early morning spike, but more importantly, this is one step closer to rewarding the tens of thousands of cancer patients who have lobbied to have Provenge approved. These patients now have hope that didn't have yesterday; and if approved, Provenge will offer an alternative over Taxotere, the only current treatment for advanced prostate cancer that is accompanied by vicious side effects.
The general market was down today, but cancer immunotherapy stocks rallied.
The Provenge story is by no means over, but today's highly anticipated news may be enough to make Dendreon's prostate cancer treatment the first American approved cancer immunotherapy treatment.
Antigenic's (AGEN) Oncophage was approved last year in Russia. AGEN nearly doubled today on the Provenge news.
I sold 50% of my position today durin the early trading spike I'll wait and see how it plays out over the next few weeks. Shorts took over for the afternoon trading, but I expect another run before the upcoming AUA conference.
Congratulations to all the prostate cancer patients who had so much hope relying on this study and congratulations to the patient investors who have supported Dendreon for years.