This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Cell Therapeutics Pulls Cancer Drug After CEO Boasted About Approval Chances

SEATTLE ( TheStreet) -- Cell Therapeutics (CTIC - Get Report) withdrew its U.S. approval application for the experimental lymphoma pixantrone due to unresolved and undisclosed "communications" with the U.S. Food and Drug Administration, the company said.

The surprise announcement from Cell Therapeutics means next Thursday's advisory committee, which was scheduled to review pixantrone, has been cancelled. The FDA will also no longer make a decision on the approvability of pixantrone on April 24, although it's relatively easy to surmise that the agency wasn't leaning towards approval given the company's decision to pull the drug's application.

Shares of Cell Therapeutics are down 17% to $1.10 in pre-market trading Monday.

Cell Therapeutics says it plans to resubmit pixantrone to FDA later this year after it has time to prepare new information. Pixantrone, if ever approved, would be used as last-line treatment for patients with aggressive non-Hodgkin's lymphoma that no longer responds to other therapies.

In March 2010, an FDA advisory panel voted 12-0 to recommend pixantrone's rejection, which the FDA later did. Cell Therapeutics appealed that rejection and resubmitted the drug last year, setting up what was supposed to be a second shot at approval this spring.

This most recent pixantrone setback is yet one more example of how Cell Therapeutics' CEO Jim Bianco fails habitually to deliver on his promises, hurting shareholders in the process. Eight years after acquiring pixantrone and promising a speedy approval, Cell Therapeutics still hasn't delivered. The same can be said for the company's other long-delayed cancer drug, Opaxio (born Xyotax).

Since late November, Bianco has been awarded with nearly $800,000 in cash bonuses by Cell Therapeutics' board, including a $150,000 bonus for 20 years service to the company.

In private conversations with Wall Street investors recently, Bianco had been predicting a positive vote from the pixantrone advisory committee meeting scheduled for Feb. 9.

The reason for Bianco's confidence: He claimed that FDA's cancer-drug review chief Dr. Richard Pazdur was dressed down by his agency superiors for an unfairly negative review of pixantrone which led to the drug's rejection in 2010.

If Pazdur had been muzzled, as Bianco boasts, the FDA's second clinical review of pixantrone could be more lenient and the panel of outside experts more likely to recommend the drug's approval, according to investors who have met with the Cell Therapeutics CEO recently.
1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
CTIC $0.48 -6.20%
AAPL $93.91 0.29%
FB $117.80 -0.65%
GOOG $694.71 -0.50%
TSLA $233.22 -3.50%


Chart of I:DJI
DOW 17,698.80 -192.36 -1.08%
S&P 500 2,058.67 -22.76 -1.09%
NASDAQ 4,759.78 -57.8140 -1.20%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs