This Day On The Street
Continue to site right-arrow
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
TheStreet Open House

Exelixis Announces Fourth Quarter And Full Year 2012 Financial Results

Stocks in this article: EXEL

Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and year ended December 31, 2012.

Q4 2012 Highlights and Recent Events

  • The FDA approved COMETRIQ™ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC) on November 29, 2012. Approval was based on the results of EXAM, a randomized phase 3 clinical trial conducted under a Special Protocol Assessment in 330 patients with progressive, metastatic MTC, which met its primary efficacy endpoint progression-free survival (PFS). The median PFS on the cabozantinib arm was 11.2 months versus 4.0 months on the placebo arm, an improvement by 7.2 months. The hazard ratio was 0.28, (95% CI 0.19, 0.40), p < 0.0001.
  • Announced in November 2012 that the European Medicines Agency (EMA) completed validation and accepted for review Exelixis' marketing authorization application (MAA) for COMETRIQ for the proposed indication of treatment of progressive, unresectable, locally advanced or metastatic MTC. Completion of the MAA validation process confirms the submission is sufficient to permit a substantive review for marketing authorization in the European Union.
  • Announced in early January 2013 that Exelixis plans to initiate phase 3 pivotal trials of cabozantinib in advanced hepatocellular cancer (HCC) and metastatic renal cell cancer (RCC).
  • Announced the commercial availability of COMETRIQ for the treatment of patients with progressive, metastatic MTC on January 24, 2013.

“Exelixis achieved an important milestone in the fourth quarter of 2012 with the approval of our first product, COMETRIQ, for the treatment of progressive, metastatic MTC,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are proud of this important clinical and regulatory achievement and pleased to have launched COMETRIQ in the progressive, metastatic MTC indication. Our focus moving forward remains on expanding the commercial franchise for cabozantinib. Our primary objective in 2013 is to execute on the broad cabozantinib clinical development program, including our COMET pivotal trial program in metastatic, castration-resistant prostate cancer (CRPC), planned pivotal trials in HCC and RCC, and additional randomized phase 2 trials to generate data that continue to differentiate the compound and allow us to maximize its clinical and commercial potential.”

1 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link 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

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, 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
Try it NOW
Try it NOW
Try it NOW
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!

Markets

DOW 17,387.21 -291.49 -1.65%
S&P 500 2,029.55 -27.54 -1.34%
NASDAQ 4,681.4970 -90.2660 -1.89%

Partners Compare Online Brokers

Free Reports

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