Dendreon (DNDN), which develops vaccines that boost a patient's immunity against cancer, could soon get a big lift from the Food & Drug Administration. The FDA is expected to announce that Dendreon may speed up its Phase 3 clinical trials on Provenge, a therapeutic vaccine for hormone-resistant prostate cancer. That would expedite Dendreon's application for final approval of Provenge.
Prostate cancer is the most common cancer among American men, says Mark Monane of investment firm Needham, who rates the stock a buy. Trading at 11 last year, the stock is now at 4, reflecting the biotech slump. Results of Provenge's first Phase 3 trial showed good results, says Mitchell Gold, who takes over as CEO on Jan. 1, 2003. The second Phase 3 trials now under way--with only advanced-prostate-cancer patients enrolled--will provide pivotal evidence needed to seek FDA approval. Overall, Provenge was well tolerated, says Gold, with the most common side effects being chills and fever, which were most often infusion-related. Needham's Monane expects the company to be in the black by 2004, when he forecasts earnings of 88 cents a share. By Gene Marcial