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!

J&J's Stent Gets a Nod From FDA Panel

A Food and Drug Administration advisory panel voted Tuesday to recommend approval of a new drug-coated stent, dubbed Cypher, made by Johnson & Johnson (JNJ - Get Report).

Stents -- which resemble wire-mesh tubes -- are used to keep arteries open after angioplasty. Cypher is an innovation to this technology that adds a drug coating to the stent, which is designed to halt cell growth and prevent restenosis, or reclogging of the arteries.

As many as 30% of patients who have ordinary stents installed must undergo further surgery within a year to clear reclogged arteries.

Wall Street analysts believe that FDA approval of drug-coated stents could double sales for the devices to $5 billion in the next few years.

Johnson & Johnson took its first big step toward getting Cypher approved Wednesday night when the FDA's Circulatory Systems Devices Panel gave the drug-coated stent a thumbs-up after a day's worth of discussion and review. The positive recommendation will now be forwarded to the full FDA, which is expected to render a decision late this year or early next year. The full FDA usually -- although not always -- follows the panel recommendation.

While positive, Wednesday's panel meeting was not without some bumps. In a surprising disclosure, the FDA issued a deficiency letter to Johnson & Johnson, regarding Cypher, on Sept 18. Details of the letter were not disclosed, although company officials said issues were resolved earlier this week. It's not clear what impact these apparent FDA concerns will have on their decision to approve the Cypher stents.

Johnson & Johnson shares closed Tuesday down 2% to $59.82.

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!


DOW 17,672.60 -141.38 -0.79%
S&P 500 2,051.82 -11.33 -0.55%
NASDAQ 4,757.8790 +7.4820 0.16%

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