ARTICLE | Company News

Dendreon up on Provenge update

September 15, 2005 1:30 AM UTC

DNDN rose $0.79 (13%) to $7.02 on Wednesday after the company said that based on discussions with FDA, it believes survival data from the Phase III D9901 trial and "supportive" data from the Phase III D9902A trial are sufficient to serve as the clinical basis for a BLA submission for Provenge to treat advanced prostate cancer. The company still expects to submit a BLA in 2006.

Neither of those trials met primary endpoint of time to disease progression (TTP) in the overall population. In July, DNDN said a pooled analysis of D9902A and D9901 showed a statistically significant 23% increase in median survival in the intent-to-treat population of 225 patients (see BioCentury Extra, Thursday July 21, 2005). ...