Posts for Ticker ‘prostate cancer’

Dendreon Shares Losing House Committee Hope (DNDN)

CNBC’s Mike Huckman just announced what is going to be a disappointment for Dendreon (NASDAQ: DNDN) holders, and that may be an understatement.  The House Committee will not be forcing any action or pressing the FDA over Dendreon’s PROVENGE until FDA makes a final decision, and that could be one to three years away.  There had been hopes that the committee would uncover conflicts of interest that have been alleged by many hopeful patients and investors alike.  That doesn’t look to be in the realm of possibilities now.

As a reminder, there is still hope that the EU might actually save it when the FDA wouldn’t.

Dendreon shares are now down over 7% to $5.37, and its 52-week trading range is $3.57 to $25.25.

Jon C. Ogg
February 13, 2008

Posted on: February 13, 2008 – 3:34 pm in Biotech, FDA, , , , ,

Dendreon Sets Stage for 2008 for PROVENGE

Dendreon (NASDAQ:DNDN) has issued a press release noting that it has completed its target enrollment of 500 patients in phase III IMPACT study of PROVENGE for advanced prostate cancer.  It also noted:

  • FDA Has Agreed That Positive Survival Data from IMPACT Study Would Support Licensure of PROVENGE;
  • Interim Survival Results Expected in Second Half of 2008.

The IMPACT study is a double-blind, randomized, placebo-controlled Phase 3 trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving PROVENGE versus placebo.  Even though the company received a set back this year that may or may not allow PROVENGE onto the market, Dendreon maintains that the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application and support the efficacy claim for PROVENGE.

With this being one of the only hopes for late-stage prostate cancer patients, this ‘completed enrollment’ would have been easy to expect.  There have not yet been any trades in the pre-market, but first indications are $7.62X$8.05 versus the $7.58 close.  If there was much new data or anything that pointed to positive data there would be significant pre-market trading.

Jon C. Ogg
October 23, 2007

Posted on: October 23, 2007 – 6:55 am in Biotech, , , ,