April 28, 2009 5:54 PM
- Text
Dendreon's Provenge Beats FDA Approval Standard By Just Half a Percent; Stock Plunges Before Rally
(MoneyWatch) Dendreon's IMPACT study of its cancer vaccine Provenge beat the FDA's 22 percent "reduction in risk of death" standard by just half a percent: The company said it reduced "risk of death" by 22.5 percent today. Dendreon stock plunged on the news and trading in it had to be halted, according to the WSJ, and then rallied strongly after the results, according to Bloomberg.
Dendreon shares fell from $24.66 to $11.81 during the day, causing fears there had been a mistake at a brokerage. CEO Mitchell Gold said he did not know why the stock would do that. (In extended trading, the stock then rallied to $27.22.)
Here's a theory: The success of Provenge is so slim that investors fear either the FDA won't back it or, if it is approved, that no one will want to pay for it. From Dendreon's press release:
But good news is good news: Ultimately the market seems to have agreed with the company -- that this drug is closer to approval and commercialization than it was before, and that dying patients will try -- and pay -- anything for a chance at life.
Next stop: FDA.
Dendreon shares fell from $24.66 to $11.81 during the day, causing fears there had been a mistake at a brokerage. CEO Mitchell Gold said he did not know why the stock would do that. (In extended trading, the stock then rallied to $27.22.)
Here's a theory: The success of Provenge is so slim that investors fear either the FDA won't back it or, if it is approved, that no one will want to pay for it. From Dendreon's press release:
PROVENGE extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months) ...Bear in mind that the price of Provenge is $50,000 a year, according to the WSJ. A lot of doctors and reimbursers are going to look at 22.5 percent "more life" -- or 4.1 months -- in a terminal cancer patient and conclude that it's not worth it.
PROVENGE improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%);
But good news is good news: Ultimately the market seems to have agreed with the company -- that this drug is closer to approval and commercialization than it was before, and that dying patients will try -- and pay -- anything for a chance at life.
Next stop: FDA.
- See previous coverage of Dendreon:
- Did News of Dendreon's Provenge Results Leak the Day Before the Announcement?
- Dendreon Still Faces Hurdles for Provenge Despite Positive Phase 3 Data
- Dendreon: Pro-Provenge Activists Heap Abuse on Cancer Drug's Critics
- Vultures Circle Dendreon Even Though Jury Is Still Out on Provenge
Latest Now in MoneyWatch
- Big banks, gov't officials strike $25B deal
- LinkedIn swings back to profit
- LinkedIn doubles revenue, beats growth estimates
- Kodak to stop making digital cameras, frames
- Market cap, schmarket cap, Apple still gets no respect
- Philip Morris Int'l income up nearly 8 percent
- Survey: Small biz plans big hires in 2012
- Freddie Mac: Mortgages inch higher but stay low
- Will the European debt crisis sink Obama's re-election?
- Banks in $25B deal to settle foreclosure abuses
- Joe Coffee: Scaling up without selling your soul
- Greek agreement accomplishes nothing
- 401K plans: New rules make costs clearer
- Are women leaders selling themselves short?
- Ask the Experts: New 401(k) rules
- Mortgage lenders strike a deal
- $25B foreclosure-abuse settlement reached
Latest CBS News Headlines
on Facebook
on CBS News
- Pebble Beach: Johnson in 3-way tie; Tiger strong
- New Mom Fear
- Alcatel-Lucent returns to profit in 2011
- Afghan private security handover looking messy
on Facebook
- Adele opens up about vocal cord surgery
- Tenn. father charged with murdering couple who"unfriended" daughter on Facebook
- Mo. teen gets life in prison for murder of 9-year-old girl
on CBS News






