This Day On The Street
Continue to site right-arrow
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
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Celgene Reports Third Quarter 2012 Operating And Financial Results

Stocks in this article: CELG

During the first half of 2013, we expect a decision by the Committee for Medicinal Products for Human Use (CHMP) on REVLIMID for MDS deletion 5q and to complete enrollment in the phase III ORIGIN (CLL-008) trial in chronic lymphocytic leukemia.

Pomalidomide: The international phase III trial (MM-003) comparing pomalidomide with low-dose dexamethasone to high-dose dexamethasone in relapsed refractory multiple myeloma patients recently achieved the primary endpoint of progression-free survival, in addition to the key secondary endpoint of overall survival. The Phase I/II dose-ranging trial (MM-005) evaluating the combination of pomalidomide, dexamethasone and bortezomib continues with data expected at this year’s ASH meeting. The regulatory reviews of pomalidomide for relapsed refractory multiple myeloma are progressing with an FDA decision expected in February 2013 and a CHMP decision expected during the second half of 2013.


ABRAXANE: We are executing on the strategy to expand the label for ABRAXANE beyond the initial indication of metastatic breast cancer. In October, the FDA approved the second indication of ABRAXANE for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

The phase III trial evaluating ABRAXANE in metastatic melanoma achieved its primary endpoint of demonstrating a statistically significant improvement in progression-free survival compared to dacarbazine. Data will be presented at the Society for Melanoma Research meeting on November 11. Future regulatory and clinical strategies are being evaluated.

Results from the phase III trial in metastatic pancreatic cancer are expected in the fourth quarter of 2012. This trial randomized over 840 patients to receive gemcitabine with or without ABRAXANE. The primary endpoint is overall survival. If successful, this trial would support a sNDA submission in 2013.

Inflammation & Immunology

Apremilast: The PALACE program (PALACE-1, 2 and 3) demonstrated a robust and statistically significant clinical benefit in previously treated psoriatic arthritis (PsA) patients. Overall safety was consistent with previous experience in the phase II program with an improved tolerability profile. We anticipate presenting the PALACE-1 data at a medical meeting before year-end. Results from PALACE-4 in treatment-naïve psoriatic arthritis are expected during the first half of 2013.

4 of 7

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

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
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, 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
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

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

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,804.80 +26.65 0.15%
S&P 500 2,070.65 +9.42 0.46%
NASDAQ 4,765.38 +16.9840 0.36%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs