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

FDA Rejects J&J Leukemia Drug

The Food and Drug Administration on Thursday rejected an application by Johnson & Johnson (JNJ - Get Report) for a new drug to treat a form of blood and bone marrow cancer called acute myeloid leukemia.

The rejection wasn't a surprise; an FDA advisory committee voted 7-4 against the drug, Zarnestra, last month, saying that J&J hadn't done enough research. J&J's application was based on data from just one phase II clinical trial. The FDA usually requires three sets of clinical trials, with phase III being the largest and most comprehensive test of a drug's safety and efficacy.

J&J, in a prepared statement, says it "remains committed" to developing the drug and adds that it is studying the FDA rejection letter so it can "determine appropriate next steps." The company didn't disclose the reasons why the FDA rejected the application.

J&J was seeking FDA approval for treating elderly patients for whom ordinary chemotherapy isn't appropriate. J&J says acute myeloid leukemia will strike nearly 12,000 Americans this year.

J&J's stock lost 71 cents, or 1.1%, to $64.99.

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
JNJ $93.93 0.00%
AAPL $110.38 0.00%
FB $92.07 0.00%
GOOG $626.91 0.00%
TSLA $247.57 0.00%


Chart of I:DJI
DOW 16,472.37 +200.36 1.23%
S&P 500 1,951.36 +27.54 1.43%
NASDAQ 4,707.7750 +80.6910 1.74%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs