This Day On The Street
Continue to site
ADVERTISEMENT
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

Onyx Trips, Ariad and Pharmacyclics Shine at Blood Cancer Meeting

SAN DIEGO ( TheStreet) -- News and views from the American Society of Hematology (ASH) annual meeting, where experts and investors are gathered to hear the latest findings on blood cancer drug research:

Onyx Pharmaceuticals (ONXX) shares will likely take a hit Monday morning after the U.S. Food and Drug Administration rejected the company's request for an expedited, six-month review of the multiple myeloma drug carfilozimib.

Instead, FDA said granted a standard, 10-month review time to carfilzomib, raising questions about whether the "benefit and risk" of the drug are balanced given that Onyx is seeking approval based on a single-arm study.

FDA's approval decision date for carfilzomib is July 27, 2012, although the agency's comments suggest Onyx may need to submit additional clinical data on carfilzomib to get the drug approved. Onyx is running a large phase III study of carfilzomib with data expected in the first half of 2013, according to a company spokesperson.

Onyx's setback opens the door for Celgene (CELG - Get Report), which said Sunday night it intends to seek U.S. and European approval for its multiple myeloma drug pomalidomide based on data from a phase II study data.

Ariad Pharmaceuticals (ARIA - Get Report) highlighted improved interim results from a pivotal study of its experimental leukemia drug ponatinib on Sunday night.

Following treatment with ponatinib, 47% of chronic myeloid leukemia (CML) patients with chronic phase disease had a major cytogenic, or cellular, response, meaning a reduction in the number mutated cells to less than 35%. In the subgroup of patients with the T315I mutation, the major cytogenic response rate was 65%.

These are improved response rates compared to ponatinib data released from the same study in early November.

The pivotal study of ponatinib, dubbed PACE, enrolled 450 CML and ALL patients, all of whom are either resistant to Novartis' (NVS) Tasigna or Bristol-Myers Squibb's (BMY) Sprycel, or who have a specific genetic mutation known as T315I that makes the leukemia resistant to current therapies.

The data presented Sunday night come from an analysis of 392 patients with a median follow-up time of almost six months. Ariad expects the study to complete in the first half of next year.

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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
ONXX $0.00 0.00%
ARIA $8.91 -0.11%
CELG $114.11 -0.30%
INCY $109.28 -0.36%
PCYC $261.25 0.66%

Markets

DOW 18,023.33 -17.04 -0.09%
S&P 500 2,108.63 -3.10 -0.15%
NASDAQ 5,075.4550 -7.4740 -0.15%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs