After three years of anticipation, disappointment and controversy, the FDA has approved the Provenge prostate cancer vaccine, which threatens to revolutionize treatment. The agency endorsement comes earlier than expected, since the PDUFA date was actually May 1.
Despite the rollercoaster ride this vaccine has taken, most anaylsts expected FDA approval would be granted and, in fact, the stock has been climbing in anticipation in recent months. Trading was briefly halted today, but has since resumed and Dendreon shares have jumped about 15 percent.
Now that months of speculation over the fate of the vaccine has ended, the issues going forward will be whether Dendreon can deliver on its promise of essentially customizing a vaccine for each prostate cancer patient and the extent to which insurance coverage will suffice.