Dendreon (DNDN-NASDAQ) is benefitting from something that become thought of as a low probability event: an FDA that buckled at least a little to peer pressure. It has received confirmation that the FDA will accept either "a positive interim or final analysis of survival" from its ongoing IMPACT study to amend the Biologics License Application for PROVENGE as a late-stage prostate cancer treatment. This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.
Mitchell H. Gold, President/CEO: "We anticipate completing enrollment in the IMPACT study this year and anticipate interim survival results in 2008. We are committed to making PROVENGE available as rapidly as possible to help the many men with late-stage prostate cancer who currently have few appealing treatment options." So the translation here is that this won’t yield an immediate approval, but it could move up the date of an approval considerably. The Company anticipates net cash for operating and capital expenditures for 2007 of approximately $95 million and expects spending levels to decrease substantially in 2008 to approximately $55 million because it has already incurred many of the third-party costs necessary to prepare for the commercialization of PROVENGE. These costs include items such as third party clinical trial costs, inventory purchases, capital expenditures related to New Jersey manufacturing and other outside infrastructure costs.
Shares are up more than 50% on this news to over $10.00, and this is much sooner than would have been expected by most. It should also give the company some added oomph going into the ASCO meeting this weekend. This one is still a long way from over, but this is at least a break for the company and should keep it from facing as soon of a cash crunch.
Jon C. Ogg
May 31, 2007
Jon Ogg can be reached at [email protected]; he does not own securities in the companies he covers.
The Average American Has No Idea How Much Money You Can Make Today (Sponsor)
The last few years made people forget how much banks and CD’s can pay. Meanwhile, interest rates have spiked and many can afford to pay you much more, but most are keeping yields low and hoping you won’t notice.
But there is good news. To win qualified customers, some accounts are paying almost 10x the national average! That’s an incredible way to keep your money safe and earn more at the same time. Our top pick for high yield savings accounts includes other benefits as well. You can earn up to 3.80% with a Checking & Savings Account today Sign up and get up to $300 with direct deposit. No account fees. FDIC Insured.
Click here to see how much more you could be earning on your savings today. It takes just a few minutes to open an account to make your money work for you.
Our top pick for high yield savings accounts includes other benefits as well. You can earn up to 4.00% with a Checking & Savings Account from Sofi. Sign up and get up to $300 with direct deposit. No account fees. FDIC Insured.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Latest from 24/7
Our expert who first called NVIDIA in 2009 is predicting 2025 will see a historic AI breakthrough.
You can follow him investing $500,000 of his own money on our top AI stocks for free.