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
TheStreet Open House

Exelixis Scores FDA Approval For Thyroid Cancer Drug

Updated with new information.

SOUTH SAN FRANCISCO, Calif. ( TheStreet) -- The U.S. Food and Drug Administration approved Exelixis' (EXEL - Get Report) Cometriq to treat medullary thyroid cancer, the agency announced Thursday.

Cometriq, formerly known as cabozantinib, is the first drug developed by Exelixis to win regulatory approval.

Exelixis shares closed Thursday down 4 cents to $5.24. After a brief after-hours halt, shares fell 3% to $5.13. Cometriq's approval was widely expected.

Medullary thyroid cancer (MTC) is a rare and slow-growing form of thyroid cancer that can often be treated surgically. As a result, 500-700 patients in the U.S. per year are likely candidates for Cometriq therapy, said Exelixis management on a Thursday night conference call.

The company's MTC market size estimate is smaller than the 2,800-patient estimate derived from American Cancer Society data.

Cometriq will cost $9,900 per month. The average MTC patient will likely be on therapy for about 10 months, Exelixis said.

Exelixis did not offer sales guidance but a back-of-the-envelope calculation pegs the likely Cometriq U.S. revenue opportunity in the range of $20-40 million at peak. Exelixis is also seeking the drug's approval in Europe, where the MTC market size is similar.

A five-person contract sales force will be used to market the drug in the U.S.

Cometriq is an oral drug designed to block two major molecular pathways by which tumor cells grow. In the phase III study of advanced MTC patients, treatment with cabozantinib resulted in a median progression-free survival of 11.2 months compared to 4 months for patients treated with a placebo. Cabozantinib reduced the risk of MTC re-growth by 72% compared to placebo.

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

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
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!
EXEL $2.54 0.00%
AAPL $123.25 0.00%
FB $83.30 0.00%
GOOG $548.34 0.00%
TSLA $185.00 0.00%


DOW 17,712.66 +34.43 0.19%
S&P 500 2,061.02 +4.87 0.24%
NASDAQ 4,891.2190 +27.8570 0.57%

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