Wachovia Cautious on Interim Data from Dendreon's (DNDN) Provenge Trial; Says Rally Will Be 'Short-Lived'

October 6, 2008 2:30 PM EDT

Wachovia is out with a research note giving its thoughts on interim data from the IMPACT trial Dendreon (Nasdaq: DNDN) released this morning. The firm maintains its Market Perform rating and $5-$6 valuation range on shares of Dendreon.

The firm says its remains cautious on expectations that Dendreon's Provenge will be successful in the final analysis. Wachovia mentions several concerning points:

• the firm said it needs to see a confidence interval for this analysis as management reported that the interim analysis showed a confidence interval at the upper range that was greater than 1.0, but the integrated analysis of 9901 and 9902a demonstrated an adjusted-Cox HR at 24 months of 0.78.
  
• on prior occasions, management had indicated it designed the IMPACT study to measure a 31% decrease in the of death in the Provenge arm, meaning that a 22% reduction (as reported by Dendreon earlier) may not be sufficient to meet the primary endpoint in the final analysis.
  
• there was no futility analysis in this interim analysis nor was there a p-value given thus, there are few conclusions that can be derived from the data presented.
  
• the only covariates used in the Cox model are PSA and LDH; Wachovia said this is surprising "given that an analysis based on this specific criteria was not presented in the FDA briefing docs."

Moreover, Wachovia said it is concerning "when modifications in the statistical plan are made mid-trial as it indicates that differences, either good or bad, between trial assumptions and actuality are occurring." The firm believes that Dendreon's rally (up 34% today) will be "short lived given the broader economic and stock market outlook."

Dendreon Corporation, a biotechnology company, engages in the discovery, development, and commercialization of novel therapeutics that harness the immune system to fight cancer.

Related Categories

Analyst Comments
Insiders' Blog

Stocks Mentioned

Related Entities

• Wachovia

Add Your Comment

Name

Subject

Body

Verification can't see the text?
click here to refresh the image.
what's this?